This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

POSITION SUMMARY: 

Assist direct Manager in overseeing and leading clinical data abstractors and related operations. Partner with the Lead Quality Abstractor, and the team’s software engineers and data management specialists to operationalize end-to-end abstraction, clinical data management workflows and activities, and lending technical support. Serve as the first line of communication and point of escalation amongst the data abstractors. 

PRIMARY RESPONSIBILITIES:

• Front-line Staff Support: Serve as the primary liaison and initial point of escalation for all abstraction/team-related issues, questions, and concerns.

• New Hire Onboarding and Training: Lead training new abstractors and provide ongoing guidance until released into production level activities by supporting the development and implementation of training workflows.  

• Mentoring and Subject Matter Expertise (SME): Provide ongoing clinical guidance and mentorship to existing abstraction team members- fostering professional development. Support maintaining high standards of quality and productivity by evangelizing the utilization of standard of care guidelines. 

• Technical Support: 

  • Lead ongoing clinical and medical guidance to engineering, data management specialists, and technical staff to ensure the development of bug-free data for systems such as Electronic Data Capture Systems (ECDs), applications, and workflows. 

  • Apply Medical Coding and Classification skills to support the creation of data standardization and harmonization rules to ensure clinical data are encoded into machine readable data in one common database schema.

  • Apply Data Management knowledge (e.g., CGDM, GCP) and skills to support establishing logical relationships between clinical events within database schemas and logical rules for ensuring data are accurate, legible, contemporaneous, original, attributable, complete, and consistent for end-to-end ETL workflows. 

  • Apply Technical Skills to translate abstraction and encoding requirements to technical product requirements to support prompt engineering and design activities for all AI and LLM initiatives.  

• Data Abstraction: Advanced level review, interpretation, abstraction and data encoding. Less than 5% of patients require quality review. 

• Quality Assurance and Control: Apply and lead efforts in resolving complex or ambiguous data abstraction questions, ensuring consistent and adherence to established protocols and standards for utilizing real-world data for research, quality monitoring, and regulatory reporting using technical and analytical software such as running MACROs and using Excel/Google Sheets functions and formulas. 

• Protocol Adherence: Support developing and ensuring strict adherence to all project and research protocols, institutional review board requirements, HIPAA regulations, data management best practices (e.g., DAMA, SCDM, ACRP, and SOCRA), and organizational policies regarding patient privacy and data security. 

• Reporting: Track, analyze, and report on key abstraction and staff level metrics to support the assessment of team performance and identify areas for process improvement by gathering and structuring KPIs using software such as Excel, googlesheets Pivot tables, formulas, and functions.                                                                                

• Process Improvement: Collaborate with cross-functional teams to effectively operationalize new abstraction activities, including the rollout of new protocols, standard operating procedures, and policies and technology platforms. 

• Daily Operations: Support direct manager in daily coordination of the clinical data abstraction team's activities and workload distribution.

• Conferences and Certifications: Maintenance of all relevant clinical or technical licensures. Attend conferences relevant to role and clinical field. 

• Other duties and responsibilities to be performed as assigned. 

QUALIFICATIONS: 

• Clinical Background: U. S. licensed Nurse, PA-C, NP, or DNP is required with a Master’s degree in health sciences. Strong understanding of medical terminology, disease processes (especially cancer), standard clinical workflows, and genetic testing.

• Clinical Experience: Minimum of 5-6 years of experience in clinical data abstraction and medical records review, preferably in cancer, women’s health, rare diseases. 

• Lead Experience: Minimum of 2-3 years of direct experience supervising staff or providing team lead support to senior level management. 

• Quality and Compliance: Demonstrated commitment to data integrity, quality control processes, and adherence to HIPAA and other data privacy regulations.

• Technical Proficiency: Proficient with Microsoft Office Suite or Google Suite, creating pivot tables, creating reports, data analysis, and using  systems or databases common in data abstraction, research, or clinical data management.

• Certifications/Industry Expertise: CCDM, CCRP, ACR-P, or CRA preferred.

• Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with clinical and non-clinical teams.

• Autonomy: Proven ability to work independently, manage time effectively, prioritize and organize tasks, and meet strict productivity and quality deadlines

• General Expertise:

  • Possess a high level of initiative and self-motivation.

  • Team player; can navigate supporting highly visible projects and tasks. 

  • In-depth attention to detail and a fast learner. 

  • Responding to shifting priorities and changes.

POSITION SUMMARY

**This position is not remote, it is located in Morrisville NC**

A Sr Phlebotomist serves patients by identifying the best method for retrieving blood; preparing specimens for laboratory testing; and performing screening procedures. 

PRIMARY RESPONSIBILITIES

• Verifies test requisitions by comparing information with nursing station log; bringing discrepancies to the attention of unit personnel.

• Verifies patient by reading patient identification.

• Obtains blood specimens by performing venipunctures and finger sticks.

• Maintains specimen integrity by using aseptic technique, following department procedures; observing isolation procedures.

• Tracks collected specimens by initialing, dating, and noting times of collection; maintaining daily tallies of collections performed.

• Maintains quality results by following department procedures and testing schedule; recording results in the quality-control log; identifying and reporting needed changes.

• Maintains safe, secure, and healthy work environment by following standards and procedures; complying with legal regulations.

• Resolves unusual test orders by contacting the physician, pathologist, nursing station, or reference laboratory; referring unresolved orders back to the originator for further clarification; notifying supervisor of unresolved orders.

• Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

• Enhances phlebotomy department and hospital reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.

• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

• Must maintain a current status on Natera training requirements

• Logistical management/printing of patient reports for that area

• Billing question answering/triaging and follow-up with patients

• Scheduling pick ups from courier services - FedEx or Medspeed.

QUALIFICATIONS

• Minimum of 5 years of phlebotomy experience

• BS/BA degree (preferred)

• High School Diploma (or equivalent) required

• Phlebotomy Certificate (if required by State)

KNOWLEDGE, SKILLS, AND ABILITIES

• Ability to serve and protect the hospital community by adhering to professional standards, hospital policies and procedures, federal, state, and local requirements, and JCAHO standards.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Work in an office setting with scrubs required

• The position requires tracking of each draw 

• Ability to serve and protect the hospital community by adhering to professional standards, hospital policies and procedures, federal, state, and local requirements, and JCAHO standards.