Assoc Principal Scientist Statistical Programming, Late-Stage; Hybrid

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within the Research and Development division, quantitative scientists partner with subject matter experts to apply state‑of‑the‑art scientific methodologies and tools to support the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines.

This position supports statistical programming activities for late‑stage drug/vaccine clinical development projects. Responsibilities include the development and execution of statistical analysis and reporting deliverables such as safety and efficacy analysis datasets, tables, listings, and figures, ranging from individual clinical trials to worldwide regulatory submissions and post‑marketing support. The incumbent designs and maintains statistical databases for stakeholders in clinical development, outcomes research, and safety evaluation.

They collaborate with statistics and project stakeholders to ensure efficient project execution and serve as the statistical programming point of contact throughout the product lifecycle.

• Assurance of deliverable quality and process compliance.
• Effective deliverable development utilizing global and therapeutic area standards that optimize analysis and reporting and promote a strategic knowledge‑base data model.
• Maintaining and managing a project plan, including resource forecasting.
• Coordinating the activities of a global programming team that includes outsourced provider staff.
• Membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or related field plus 9 years or more SAS programming experience in a clinical trial environment, OR
• MS in the same fields plus 7 years or more SAS programming experience in a clinical trial environment.

• Experience leading large and/or complex statistical programming projects and coordinating a programming team.
• Broad knowledge and significant experience developing analysis and reporting statistical programming deliverables (datasets, analyses, report tables, and graphics) using global and therapeutic area standards, with emphasis on quality, compliance, and timeliness.
• Expertise in SAS and clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH); systems and database expertise; familiarity with statistical analysis methods and clinical data‑management concepts.
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level, including development of electronic submission deliverables.
• Strong project‑management skills; program leadership; determination of appropriate programming methodology, assurance of programming consistency across protocols and projects, completion of programming tasks, and direction of other programmers; experience as a programming mentor.
• Ability to comprehend statistical analysis plans and understand statistical terminology and concepts; design and develop complex programming algorithms.
• Excellent communication and negotiation skills with a history of teamwork and collaboration; ability to adapt to new projects and stakeholders.
• Strategic thinking – ability to translate strategy into tactical activities; design of statistical databases that optimize analysis and reporting while leveraging departmental standards and industry best practices.
• Experience with CDISC and ADaM standards.
• Demonstrated success in assuring deliverable quality and process compliance.
• Ability to anticipate stakeholder and regulatory requirements.

• Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
• Ability and interest to work across cultures and geographies.
• Experience providing technical and/or programming guidance and mentoring to colleagues.
• Experience completing statistical programming deliverables using global outsource partner programming staff.
• Experience developing and…