Sr. Scientist Stat Programming, Late-Stage Development; Hybrid

Responsibilities:

• Support statistical programming activities for late-stage drug/vaccine clinical development projects; may lead one or more projects.
• Develop and execute statistical analysis and reporting deliverables (safety/efficacy analysis datasets, tables, listings, figures) spanning trials through worldwide regulatory submissions and post‑marketing support.
• Design and maintain statistical datasets supporting multiple stakeholder groups (clinical development, outcomes research, safety evaluation).
• Collaborate with statistics and project stakeholders to ensure timely, high-quality deliverables.
• Serve as statistical programming point of contact and knowledge holder through the product lifecycle.

• Develop, validate, and implement analysis/report programming using global/TA standards, departmental SOPs, and good programming practices.
• Maintain and manage project plan, including resource forecasting.
• Coordinate activities of a global programming team (including outsource provider staff).
• Participate in departmental strategic initiative teams.

• BA/BS plus 5+ years SAS programming experience in a clinical trial environment.
• MS plus 3+ years SAS programming experience in a clinical trial environment.

• Interpersonal, negotiation, collaboration; strong written/oral/presentation skills.
• Experience creating R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
• Ability to independently complete project-level tasks and collaborate with stakeholders.
• SAS clinical trial programming expertise (data steps, procedures, SAS/MACRO, SAS/GRAPH) and systems/database expertise.
• Ability to design complex programming algorithms; understand analysis plans and statistical terminology.
• Familiarity with clinical data management; experience with CDISC and ADaM standards.
• Ensure process compliance and deliverable quality; strategic thinking and stakeholder requirement anticipation.

• R programming for statistical modeling/analysis/visualization.
• Regulatory application submission experience (including electronic submission deliverables).
• Program consistency across protocols/projects; mentorship; cross‑cultural/geographic teamwork.
• Experience using global outsource partner staff;
  Microsoft Project (or similar) for planning.
• Process improvement; active professional society involvement.

Apply via  (deadline stated on posting).