Alumis Inc is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. 

We are seeking a Data Science leader within Statistical Programming to advance analytical insights across clinical development while supporting high-quality, submission-ready deliverables. You will employ modern data science methods and tools such as machine learning, generative AI, and agentic AI to strengthen statistical programming and elevate analytical insight generation. You will contribute to both clinical data science (enhancing analyses, insights, and submissions) and operational/enterprise analytics (improving efficiency, scalability, and decision-making across Biometrics).  

Depending on level, this individual will operate as a hands-on study/program contributor (Senior Manager) or a program-level leader influencing strategy and cross-functional execution (Associate Director). 

Essential Responsibilities 

Clinical Evidence Generation, Analytical Insights, and Regulatory Engagement  

• Develop and deliver data science analyses to support clinical development, regulatory submissions, publications, and exploratory analyses. 
• Partner with Biostatistics to support innovative analyses (e.g., simulations, external controls, RWE integration, predictive analytics using ML/GenAI models). 
• Ensure alignment between exploratory analytics and CDISC-based submission deliverables; maintain documentation for inspection readiness. 
• Support analysis of emerging data types (e.g., biomarkers, digital endpoints, real-world data, text, imaging), ensuring interpretability and quality. 
• Contribute to responses to regulatory queries and preparation of submission materials involving advanced analytics. 

Technical Execution & Innovation 

• Develop and maintain analysis workflows using SAS and/or open-source tools (R/Python), balancing innovation with compliance. 
• Build reusable tools, macros, templates and pipelines to improve efficiency, reproducibility, and scalability. 
• Contribute to reproducible analysis pipelines (e.g., version control, data engineering and pipeline automation). 
• Support development of dashboards and visualizations (e.g., Shiny, Plotly) to communicate insights effectively. 
• Apply data science methods to improve study execution and operational insights (e.g., enrollment trends, data quality signals, feasibility). 

Cross-Functional Collaboration 

• Partner with Biostatistics, Data Management, Clinical Operations, and other stakeholders to support study and program deliverables. 
• Participate in the review of key study documents (e.g., SAPs, CRFs, DMPs, database specifications) for programming and analysis alignment. 
• Serve as a point of contact for programming and data science activities with internal teams and CRO partners. 
• Translate analytical outputs into clear, actionable insights for both technical and non-technical audiences. 

Process, Quality, & Compliance 

• Ensure all programming and data science deliverables meet regulatory, industry, and company standards (e.g., CDISC, GxP, 21 CFR Part 11). 
• Contribute to the development and continuous improvement of programming and data science standards, processes, and SOPs. 
• Stay current on evolving regulatory movement related to data science, AI/ML, and analytics in drug development. 

Leadership and Scope Differentiation  

• Senior Manager: 
  • Lead data science activities at the study level; operate as a hands-on contributor delivering analyses and tools.
    
    
• Associate Director: 
  • Provide program-level oversight across multiple studies; influence data science strategy and cross-functional alignment. 
  • Contribute to shaping data science standards, tools, and longer-term capabilities within Statistical Programming. 
  • Mentor junior team members and guide CRO partners. 

The Ideal Candidate 

• Strong experience in SAS, R or Python for data analysis and visualization. 
• Experience in Data Science methods and tools: Machine Learning models and model development lifecycle, GenAI/Agentic AI application development as a plus 
• Experience supporting clinical development and regulatory submissions in a pharma/biotech or CRO setting. 
• Hands-on experience with CDISC standards (SDTM, ADaM) and integration with exploratory analytics. 
• Experience working with diverse data types (clinical, biomarker, or real-world data) and data engineering pipeline development. 
• Experience with reproducible research practices (e.g., version control, structured workflows). 
• Ability to analyze complex datasets and translate findings into actionable insights. 
• Strong communication and collaboration skills across technical and non-technical stakeholders. 
• Detail-oriented with a strong commitment to quality and accuracy. 
• Therapeutic experience in autoimmune/immunology is a plus. 

In addition, for Associate Director level: 

• Experience influencing program-level strategy across multiple studies or indications. 
• Demonstrated ability to drive cross-functional alignment and contribute to analytical strategy. 
• Experience mentoring team members and overseeing CRO/vendor deliverables. 
• Exposure to advanced analytics approaches (e.g., causal inference, simulations, RWE integration) in a regulated environment. 

Education & Experience 

• Senior Manager: 
  • Bachelor’s degree (or equivalent) with 8+ years of experience, or Master’s with 6+ years 
    
    
• Associate Director: 
  • Bachelor’s degree (or equivalent) with 10+ years of experience, or Master’s with 8+ years 

This role is located in South San Francisco, CA, with an on-site presence expected Tuesday through Thursday. Remote candidates may remain off-site but should be willing to travel regularly for team collaboration.

Alumis Inc. is an equal opportunity employer.

The salary range for this position is Senior Manager: $180,000 - $200,000 annually and Associate Director: $200,000 - $220,000 annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Alumis compensation packages include generous stock option grants for all employees as well as an annual bonus program.

Other benefits include:

• Health insurance premiums paid at 90% for employee, 80% for dependents
• Free access to Genentech Bus & Ferry Share program
• $100 monthly cell phone stipend
• Unlimited PTO for Exempt employees
• Free onsite gym and a kitchen stocked with yummy snacks and drinks!

We are a hard-working, collaborative team on a mission to transform patient’s lives-- and we aspire to elevate, challenge and nurture one another along the way.

The Director, Data Systems (DS) and Clinical Programming (CP) will be responsible for leading and managing the Clinical Programming function within Data Management (DM). This position will report to the VP, Data Management and Clinical Programming.

Responsibilities: 

• Lead and manage the Data Systems and Clinical Programming function within DM
• Drive the implementation of various technology solutions to augment existing DM processes, optimize efficiency and enhance overall data quality assurance
• Lead and/or participate in AI-related initiatives for DM
• Develop and implement strategies for optimizing data flow, database builds, and integration of external technologies.
• Oversee the validation of the EDC platform, ensuring ongoing system optimization.
• Manage relationships with key external vendors, ensuring alignment with organizational goals.
• Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data.
• Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements.
• Collaborate with other departments to align data strategy with broader organizational goals and objectives.
• Mentor and develop team members, fostering a culture of continuous learning and growth within the team.
• Oversee all SAS clinical programming requests and standardize the clinical programming specification development process.
• Develop and/or maintain Alumis’ standard CRFs and standard edit checks, inclusive of indication-specific standards.
• Develop DS&CP SOPs and Work Instructions.
• Lead the development and/or maintenance of standard vendor Data Transfer Agreements (DTAs).
• Oversee the development and execution of technical initiatives within DM, including the implementation of key data visualizations and dashboards for DM, such as Clean Patient Tracking, data currency, and rolling batch freeze progress.
• Integrate the usage of data analytics within DM to further optimize current processes.
• Provide strategic oversight of high-priority projects, including database builds, user access management, and the release of system updates.
• Participate in EDC, IRT and eCOA User Acceptance Testing (UAT)
• Ensure accurate development and execution of data integrations between EDC, IXRS or additional external vendor data sources
• Ensure DS&CP study-specific documentation is in an inspection-ready state and represent the DS&CP function in inspections as applicable.
• Represent DS&CP in cross-functional meetings as applicable
• Act as a key stakeholder in developing and executing strategies to accelerate drug development through innovative data management practices.

Qualifications: 

• 12+ years of relevant experience and has earned a BS or equivalent degree; MS or MBA a plus
• Experience supporting Ph I-IV clinical trials, both in-house and through CRO partners
• Strong knowledge and experience in EDC and other key technologies (e.g., IXRS, data visualization) 
• Proficiency in CDISC standards (CDASH, SDTM, ADaM)
• Experience with SAS, SQL and/or other clinical programming tools
• Proficiency in clinical research regulations and guidance, including FDA CFR and ICH GCP 
• Depth of experience across all aspects of DM, including but not limited to: CRF and database development, data quality assurance and analytics, data transfer management, vendor management, DM study documentation and inspection readiness. 
• Strong understanding of the application of MedDRA and WHO Drug clinical data coding classification systems
• Strong interpersonal, organizational, and communication (oral and written) skills
• Demonstrated ability to cultivate strong working relationships with internal and external colleagues.
• Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
• Ability to prioritize and to adapt quickly to changing business conditions with a “can-do” attitude
• Capable of proactively identifying project challenges and risks and proposing appropriate and strategic solutions to issues.
• Willing to travel if required  

Alumis Values 
• We Elevate 
• We Challenge 
• We Nurture 

This position is located in South San Francisco, CA and employees are expected to be onsite Tuesday-Thursday. Open to remote applicants with requirement to be onsite 1-2x a quarter.

The salary range for this position is $200,000 USD to $225,000 USD annually. This salary range is an estimate, and the actual salary may vary based on the Company’s compensation practices.

Alumis Inc. is an equal opportunity employer.