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

Job Description

• Support statistical programming for late‑stage drug and vaccine clinical development projects.
• Lead one or more projects as required.
• Develop and execute statistical analysis and reporting deliverables (safety and efficacy datasets, tables, listings, figures) from individual trials to worldwide regulatory submissions and post‑marketing support.
• Design and maintain statistical datasets for multiple stakeholders, including clinical development, outcomes research, and safety evaluation.
• Collaborate with statistics and other project stakeholders to ensure efficient execution of plans with timely, high‑quality deliverables.
• Serve as the statistical programming point of contact and knowledge holder throughout the product lifecycle.

• Develop and validate effective analysis and report programming following global and therapeutic area standards, departmental SOPs, and good programming practices.
• Maintain and manage project plans, including resource forecasting.
• Coordinate activities of a global programming team, including outsourced provider staff.
• Participate on departmental strategic initiative teams.

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field plus a minimum of 5 years SAS programming experience in a clinical trial environment.
MS in the same disciplines plus a minimum of 3 years SAS programming experience in a clinical trial environment.

• Effective interpersonal skills and ability to negotiate and collaborate effectively.
• Excellent written, oral, and presentation skills.
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
• Project leadership: completes tasks independently at a project level and collaborates with key stakeholders.
• Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, systems, and database expertise.
• Designs and develops complex programming algorithms.
• Ability to comprehend analysis plans describing methodology to be programmed and an understanding of statistical terminology and concepts.
• Familiarity with clinical data management concepts.
• Experience in CDISC and ADaM standards.
• Ensures process compliance and deliverable quality.
• Strategic thinking to translate strategy into tactical activities, design statistical databases with the end in mind, optimize analysis and reporting, and leverage departmental standards and industry best practices.
• Ability to anticipate stakeholder requirements.

• Experience using R for statistical modeling, data analysis, and visualization.
• Demonstrated success in ensuring deliverable quality and process compliance.
• Strong working knowledge of reporting processes (SOPs) and software development life‑cycle (SDLC).
• Experience with US and/or worldwide drug or vaccine regulatory application submissions, including development of electronic submission deliverables.
• Experience ensuring programming consistency across protocols and projects, directing other programmers, and mentoring programmers.
• Ability and interest to work across cultures and geographies.
• Ability to complete statistical programming deliverables using global outsource partner programming staff.
• Experience developing and managing project plans using Microsoft Project or similar.
• Active in professional societies.
• Experience in process improvement.

Salary range: $ – $. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable.

We offer a comprehensive benefits package, including medical, dental, vision, other insurance benefits, retirement benefits (including 401(k)), paid holidays, vacation, compassionate days, and sick days.

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that reflects their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics.

As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about your rights, please consult EEOC resources.