The Opportunity:

Playing a critical role as a filing and program lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.

• Lead strategic, statistical thinking and contributions to clinical development plans.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Extensive experience in design and conduct of phase 3 oncology trials.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Experience with lead role in NDA/BLA filing desirable.

#LI-Hybrid  #LI-SH1

The Opportunity:

Position requires 14+ years of Statistical Programming experience with exploratory-stage oncology clinical trials, providing programming support and oversight of one or more clinical programs (early or late phase) within Statistical Programming function. In addition to hands-on Programming, this position requires providing oversight and programming support and guidance for internal deliverables and regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Based on company needs, this position will be required to lead one or more early Phase or late phase studies/programs. Specific responsibilities include:

• Effective collaborating with cross functional teams to provide programming timelines for various deliverables.

• Provide SAS Programming technical support and guidance to programming team.

• Oversight/participation in any internal/mock or regulatory authority audits.

• Timeline and vendor management for deliverables, including submission-related activities,  complying with regulatory standards (e.g., FDA 21 CFR Part 11, GxP).

• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), blank and annotated CRFs, and actual patient CRFs.

• Hands-on programming and management of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

• Oversight and Verification Review of documents, spreadsheets, slides for in-house presentations and external publications.

Titles may vary based on candidate experience.

Required Skills, Experience and Education:

• 14+ years of Statistical Programming experience with early or late phase oncology trial studies.

• BS/BA degree or other suitable qualification with relevance to the field.

• Experience leading one or more statistical programming contractors, and programming vendors.

• Proficiency in providing hands-on SAS Programming support for production or validation of analysis datasets, tables, listings and figures.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

Preferred Skills:

• A demonstrable record of strong leadership and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

• Experience working in a small to mid sized biotech/pharma environment.

• Experience collaborating on development of processes, SOPs and guidance documents for the Statistical Programming function. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

This position is to serve as a study level statistician for oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables. 

• Represent biostatistics on study/project teams.

• Provide statistical expertise for design, analysis and reporting of clinical studies.

• Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis.

• Develop statistical analysis plans and analysis specifications.

• Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications.

• Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.

• Provide statistical input to regulatory interaction and response to health authority submissions.

• Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation.

• Contribute to the development of functional-level standards, SOPs, and templates.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician for clinical trials. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of oncology trials is a must.

• Ability to work independently and within a team.

• Ability to apply statistical knowledge to solve real-world problems and acquire new knowledge in advanced statistical methods (e.g., Bayesian methods, predictive modeling etc.).

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

#LI-Hybrid #LI-EM1

The Opportunity:

This position has a key role in the day-to-day management of Clinical Data Management (CDM) activities. Including timely and professional management of clinical trial data for all relevant phases. Represents Revolution Medicines (RevMed) CDM in Clinical Team meetings. The Director, Clinical Data Management, will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency, and completeness. Manage external vendors providing clinical data. Manages and/or perform data management tasks according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Provides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers.

• Plans, coordinates, and manages CDM tasks for clinical studies.

• Participate and review CRO proposals.

• Acts as primary liaison with CROs, third party data vendors, EDC vendors.

• Reviews clinical protocols and cross functional plans.

• Serves as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines.

• Overseas and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock.

• Ensures Data Management Plans are followed through the course of the studies.

• Sets and manages Data Management project timelines.

• Provides comprehensive status updates to project team members.

• Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation.

• Assist in defining and creating data listings, summary table validation, data specifications, and process data transfers in preparation for statistical review and data management audit.

• Implements data standardization and maintains data model across projects.

• Direct management and mentoring responsibilities for internal data management team members.

• Lead department initiatives e.g., development of SOPs.

• Other duties as assigned.

Required Skills, Experience and Education: 

• MS, BS/BA degree, or other suitable qualification with relevance to the field.

• 15 or more years’ direct experience of designing and running early-stage or late-stage clinical trials.

• Knowledge of, and experience with, clinical databases, standards, medical terminology, medical coding dictionaries, quality control processes, and auditing procedures.

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.

• A demonstrable record of strong leadership and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

• Excellent written and verbal communication skills.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

• Experience from industry is essential.

Preferred Skills:

• Oncology experience, especially in solid tumors.

• 5 or more years’ direct line management experience. 

  #LI-Hybrid  #LI-DN1

The Opportunity:

Playing a critical role as a lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.

• Lead strategic, statistical thinking and contributions to clinical development plans.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Extensive experience in design and conduct of phase 3 oncology trials.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Experience with lead role in NDA/BLA filing desirable. 

  #LI-Hybrid  #LI-SH1

Opportunity: 

The Senior Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials.  The Sr/CDM has a broad, fundamental knowledge of the data management process and can plan, manage and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs).  The core duties and responsibilities of the Sr/CDM are delineated below. Specifically, you will be responsible for:

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.

• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.

• Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).

• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.

• Provides oversight of database set-up/migrations/updates including coordinating and performing UAT

• Leads the development of internal Data Review Plan and coordinates cross functional team data listing review.

• Coordinates the internal medical coding review.

• Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.

• Performs external data reconciliation against EDC.

• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.

• Executes and/or distributes data management metrics, listings, and reports.

• Provides oversight of data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.

• Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.

• Provides training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Maintains study DM related documents/files for inspection readiness.

• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).

• Participates in CRO/vendor selection process for outsourced activities.

• Supports budget and resource planning across assigned projects.

• Participates in the development, review and implementation of departmental SOPs, templates, and processes.

• Participates in department or cross-functional initiatives (as needed).

• Contributes to a professional working environment through exemplifying RevMed Core Values.

Required Skills, Experience and Education:

• Bachelor’s degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field.

• At least five (5) years for Sr. CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement.

• Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.

• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).

• Knowledge of industry standards (CDISC, SDTM, CDASH).

• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.

• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.

• Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.

• Proven ability to work both independently and in a team setting.

Preferred Skills:

• Bachelor's degree in health sciences, Life Sciences, or health-related field

• CRO/Service provider management experience.

• Prior oncology/solid tumor experience highly desired

• Knowledge of industry standards (CDISC, SDTM, CDASH).

• Working knowledge of statistical programming packages (e.g. SAS) is a plus.

#LI-Hybrid  #LI-JC1

The Opportunity:

The Senior Director of Clinical Data Management provides high-level leadership for data management functions within clinical research, focusing on strategic development, operational execution, and regulatory compliance to ensure data integrity for clinical trials. Key responsibilities include leading and managing data management teams, establishing and enforcing data management policies and procedures, overseeing departmental budgets, collaborating with cross-functional teams and vendors, and ensuring data management processes meet regulatory standards. This role requires extensive experience in clinical data management, strong leadership and communication skills, expertise in clinical trial methodologies, and a deep understanding of regulatory requirements including submissions and data management systems.

Required Skills, Experience and Education:

• Define and implement the overall vision, strategy, and goals for the clinical data management department, including developing and enforcing departmental SOPs.

• Lead, manage, and develop data management teams, handling resource planning, staff training, and performance reviews.

• Develop and monitor KPIs for data quality and operational performance.

• Manage relationships with Contract Research Organizations (CROs) and other data management vendor partners, ensuring they meet quality and performance standards.

• Forecast, manage, and provide oversight for departmental budgets, including internal and external expenditures.

• Ensure data integrity, quality, and compliance with regulatory requirements (e.g., FDA, ICH, GCPs) and internal company policies.

• Experience with global trials and regulatory submissions (FDA, EMA).

• In-depth understanding of industry standards related to clinical data management (e.g., medical dictionary coding).

• Guide data management activities for regulatory submissions and represent the department during regulatory inspections and internal audits.

• Serve as a key liaison and collaborate effectively with cross-functional teams (e.g., Clinical, Quality, Regulatory) and key external stakeholders.

• Extensive experience in clinical data management and systems, with proven leadership experience in oncology therapeutic area.

• Proficient knowledge of EDC systems (e.g., Medidata Rave), CDISC standards, and clinical trial processes.

• Drive innovation and continuous process improvement within data management by implementing new technologies and advanced systems to enhance productivity and efficiency.

• Demonstrated ability to lead, motivate, and develop teams.

• Excellent communication and interpersonal skills to effectively collaborate with diverse teams and stakeholders.

• Strong problem-solving and decision-making abilities to resolve complex issues and drive solutions.

• MS, BS/BA degree, or other suitable qualification with relevance to the field.

• 17 or more years’ direct experience in clinical data management in the biotechnology OR Pharmaceutical industry.

Preferred Skills:

• A degree in life science, health informatics, or a related field.

• Exposure to real-world data (RWD) and decentralized trial models.

• Automation and digital transformation initiatives to improve data quality and efficiency (e.g., IXRS, AI/ML tools, RBQM platforms). #LI-Hybrid  #LI-DN1

The Opportunity:

The Senior Scientist I in Clinical Biomarker Development team, within the Translational Medicine will play a key role in the design, execution, and interpretation of clinical biomarker strategies across Revolution Medicine’s oncology pipeline. You will:

• Design and execute clinical biomarker strategies to support early response monitoring, patient stratification, and understanding resistance mechanisms.

• Support biomarker implementation for early- and late-stage oncology clinical trials.

• Oversee biomarker assay development, qualification, and sample analysis in collaboration with internal teams and external CROs.

• Analyze and interpret biomarker data in the context of clinical outcomes and present results to cross-functional teams.

• Contribute to clinical protocols, study reports, and regulatory documents (e.g., INDs, IBs, CSRs).

• Translate preclinical findings into clinically actionable biomarker hypotheses.

• Stay current with emerging biomarker technologies and trends in precision oncology.

Required Skills, Experience and Education:

• PhD in a relevant scientific discipline with 3+ years of relevant industry experience in clinical biomarkers, translational medicine, or related roles.

• Experience supporting oncology clinical trials with biomarker components.

• Familiarity with biomarker platforms such as genomic/molecular and proteomic assays.

• Experience working with CROs and managing external vendors.

• Strong scientific communication skills and ability to work cross-functionally.

Preferred Skills:

• Experience with targeted oncology therapies or RAS/MAPK pathway biology.

• Biological understanding of pancreatic, non small cell lung and/or colorectal cancers is preferred.

• Familiarity with analytical software for data anlaysis and interpretation. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Biostatistics summer intern will work for 8-12 weeks under the supervision of experienced Biostatisticians on theoretical or applied problems with direct relevance to on-going clinical drug development research in Oncology. During the internship, the student is expected to implement new methodological developments using SAS/R and conduct simulation studies as needed. At the end of the internship, the student is expected to give a department-wide presentation on their research topic and prepare a final written report.

Required Skills, Experience and Education:

• Must have strong programming skills in SAS or R.

• Must have a solid background on survival analysis.

• Demonstrated problem-solving ability and strong oral and written communication skills.

• Enrollment in a full-time graduate program and have completed at least two full years of graduate course work prior to the start of the internship.

Preferred Skills:

• Familiarity with advanced statistical methods including ML, causal inference, Bayesian statistics, external control and observational studies. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking a highly motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data Science Biostatistics group. This role will provide strategic and hands-on statistical leadership for exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) initiatives. The successful candidate will serve as a key statistical leader and individual contributor, partnering closely with cross-functional teams to generate high-quality evidence that advances our oncology pipeline and supports medical and scientific strategy.

• Provide statistical leadership for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Serve as a primary statistical contact for assigned projects, working collaboratively with clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial.

• Lead the design, analysis, and interpretation of complex statistical models, including survival analysis, machine learning, and casual inference methodologies.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

• Mentor and provide technical guidance to junior statisticians, fostering scientific rigor, innovation, and professional growth.

• Contribute to regulatory and payers/HTA agencies interactions, scientific publications, abstracts, and internal decision-making through clear and effective communication of statistical results.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Proven ability to independently lead statistical aspects of complex, cross-functional projects.

• Strong understanding of regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Excellent interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and studies and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle. 

• Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team’s preparation for company governance reviews.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of oncology trials is a must.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Active participation in NDA/BLA filing through label negotiations desirable. #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a highly motivated PhD- or Master’s-level intern to support deployment, optimization, and validation of the FACETS pipeline.

• Deploy, optimize, and harden the FACETS pipeline for WES and targeted panel tumor/normal datasets.

• Automate preprocessing, segmentation, and allele-specific copy-number calling workflows.

• Run large-scale benchmarking and QC evaluations.

• Integrate FACETS outputs into downstream pipelines.

Required Skills, Experience and Education:

• Current PhD or Master's student in relevant fields.

• Strong understanding of NGS, CN analysis, statistical modeling.

Preferred Skills:

• Experience with FACETS or similar tools; workflow engines; cloud environments. 

  #LI-Hybrid  #LI-AP1

The Opportunity:

We are seeking a highly capable Associate Director of Biostatistics to join our Medical Analytics and Exploratory Data Science Biostatistics group within our Biostatistics organization. This role will play a critical part in the design, analysis, and interpretation of exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) studies. The successful candidate will serve as a key statistical contributor and emerging leader, partnering closely with cross-functional teams to deliver high-quality, data-driven insights that support scientific understanding and evidence generation.

• Lead statistical design, analysis, and interpretation for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial, to execute evidence generation plans.

• Apply appropriate statistical methodologies, including survival analysis, machine learning, and casual inference approaches, to address complex scientific and medical questions in oncology.

• Contribute to the development of analysis plans, technical specifications, and interpretation of results under general direction from senior statistical leadership.

• Support cross-functional evidence generation planning by providing statistical input into study design, feasibility, and analysis strategies.

• Review and oversee statistical deliverables produced by internal programmers or external vendors/contractors to ensure scientific quality and consistency with standards.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Assist with the preparation of scientific communications, including abstracts, manuscripts, posters, and internal presentations.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Ability to work independently and within a team.

• Ability to independently execute statistical analyses for moderately complex projects with guidance from senior statisticians.

• Familiar with regulatory requirements related to biostatistical activities and clinical trials.

• Strong verbal and written communication skills are required.

• Strong interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

Playing a critical role as a Manager, Biospecimen Operations within Translational Medicine function, the position will be providing biomarker operational expertise in, developing scope of work, and maintaining effective working relationships with cross-functional teams for phase three clinical trials.

• Lead end‑to‑end biomarker operations across Phase I–III oncology clinical trials, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting.

• Collaborate cross‑functionally with Biomarker Leads, Companion Diagnostics, Clinical Operations, and Data Management on reviews of protocol, ICF, eCRF, DTS, Genomic Verification Forms, and eTMF documentation to ensure operational alignment.

• Oversee central lab activities, including operational lab startup, lab manual and site requisition form, SOW reviews and budget evaluation.

• Manage relationships with specialty biomarker labs, including sample logistics oversight, testing strategy alignment, RUO data transfer execution, issue and query resolution, invoice review, and coordination of recurring operational meetings.

• Contribute to SOP development, operational process optimization, and biomarker program initiatives to support biomarker operation excellence.

• Support TM deliverables, including IA data reviews, CSR, and regulatory submissions for CDx filings.

• Drive vendor selection, qualification, onboarding, and participate in audits to ensure adherence to regulatory and quality standards.

• Provide biomarker operational metrics and study updates to cross‑functional teams and senior leadership to support strategic decision‑making

• Review ICFs and respond to EC and IRB inquiries related to biomarker components.

• Collaborate closely with Pharmacokinetic (PK) Leads to support PK operations and ensure timely delivery of all PK‑related clinical milestones.

• Bring experience in diagnostic operations supporting CDx development and regulatory filings, including sPMA submissions.

• Utilize IRT and EDC systems to enable real‑time sample tracking, data integration, and prompt query resolution.

Required Skills, Experience and Education:

• Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.

• 7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.

• Should have experience mentoring team members.

• Prior experience in clinical biomarker and CDx operations in phase one to three clinical trials is strongly preferred.

• Prior experience in TruTech, SLOPE and LIMS platforms is highly desirable.

• Excellent scientific and business communication skills, strong interpersonal/collaboration skills, and planning skills.

• Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.

• Experience in using Project Management tools is highly desired.

• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Ability to multi-task and thrive in a fast-paced innovative environment.

• A great teammate, who listens effectively and invites response and discussion.

• Commitment to Revolution Medicines’ Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Preferred Skills:

• Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.

• Experience in using Project Management tools is desirable.

• Experience in using LIMS Sample Management tool is desirable.

• Experience with next-generation sequencing (NGS) methods for RAS mutation analysis is desirable. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

The Senior Scientist I in Clinical Biomarker Development team, within Translational Medicine will play a key role in the design, execution, and interpretation of clinical biomarker strategies across Revolution Medicine’s oncology pipeline. You will:

• Design and execute clinical biomarker strategies to support early response monitoring, patient stratification, and understanding resistance mechanisms.

• Support biomarker implementation for early- and late-stage oncology clinical trials.

• Oversee biomarker assay development, qualification, and sample analysis in collaboration with internal teams and external CROs.

• Analyze and interpret biomarker data in the context of clinical outcomes and present results to cross-functional teams.

• Contribute to clinical protocols, study reports, and regulatory documents (e.g., INDs, IBs, CSRs).

• Translate preclinical findings into clinically actionable biomarker hypotheses.

• Stay current with emerging biomarker technologies and trends in precision oncology.

Required Skills, Experience and Education:

• PhD in a relevant scientific discipline with 3+ years of relevant industry experience in clinical biomarkers, translational medicine, or related roles.

• Experience supporting oncology clinical trials with biomarker components.

• Familiarity with biomarker platforms such as genomic, transcriptomic and proteomic assays.

• Experience working with CROs and managing external vendors.

• Strong scientific communication skills and ability to work cross-functionally.

Preferred Skills:

• Experience with targeted oncology therapies or RAS/MAPK pathway biology.

• Biological understanding of pancreatic, non-small cell lung and/or colorectal cancers is preferred.

• Familiarity with analytical software and analytical capabilities for integrating clinical and biomarker datasets. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and the subject matter expert (SME) in Biostatistics within the Quantitative Sciences function, this position is to provide statistical leadership and support for EU access strategies, healthcare technology assessments and regulatory submissions. 

• Serve as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches in collaboration with global and regional crossfunctional teams.

• Partner with Regional and Local Market Access and HEOR functions to design and lead/oversee the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network meta-analyses, and RWE generation.

• Partner closely with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post-authorization commitments.

• Ensure statistical methodologies align with EU guidance (ICH, EMA guidelines, CHMP expectations). 

• Contribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions.

• Provide statistical expertise and support for regional study projects including study design, data analysis, and interpretation of results, to ensure high-quality and scientifically sound outcomes.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Drive and lead department initiatives, best practices, and guidelines.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics or related fields, a minimum of 10 years (for Ph.D.) and 15 years (for M.S.) of experience in the biotech/pharma industry as a statistician.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Advanced methodological and technical skills.

• Strong problem solving and critical thinking abilities.

• Proficiency in SAS and/or R.

Preferred Skills:

• Strong track record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as well as reimbursement dossier contributions in major European markets.

• Experience in engaging with European scientific advice/early payer.

• Deep understanding of evolving landscape of EMA, MHRA and Swissmedic, and the evolving landscape of joint clinical assessments (JCA) in Europe, in addition to European legislation requirements.

• Active participation in NDA/BLA filing through label negotiations advantageous.

• Hands-on experience in design and analysis of oncology trials.

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The Opportunity:

The Biostatistics summer intern will work for 8-12 weeks under the supervision of experienced Biostatisticians on theoretical or applied problems with direct relevance to on-going clinical drug development research in Oncology. During the internship, the student is expected to implement methodological developments using SAS/R and conduct simulation studies as needed. At the end of the internship, the student is expected to give a department-wide presentation on their research topic and prepare a final written report.

Required Skills, Experience and Education:

• Must have strong programming skills in SAS or R.

• Must have a solid background on survival analysis.

• Demonstrated problem-solving ability and strong oral and written communication skills.

• Enrollment in a full-time graduate program and have completed at least two full years of graduate course work prior to the start of the internship.

Preferred Skills:

• Familiarity with advanced statistical methods, including casual inference, Bayesian statistics, covariate-adjusted modeling.

• Experiencee with simulation-based methods and predictive modeling to support the clinical development decision. 

  #LI-Hybrid  #LI-AP1