Associate Principal Scientist, Biostatistics

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists work with subject matter experts to apply state‑of‑the‑art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

• Develop, coordinate, and provide biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
• Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other R&D Division scientists to design and analyze clinical trials, and coordinate statistical activities for clinical drug/vaccine projects; may interact with Contract Research Organization (CRO).
• Serve as statistical lead in project teams.
• Initially work in a specific disease area.

• Serve as statistical representative and lead in cross‑functional teams for strategic planning and execution of product development.
• Participate in clinical development planning to ensure study designs align with program objectives and regulatory/marketing needs.
• Identify and anticipate technical or other potential problems in the design, conduct, and analysis of clinical trials; propose and implement solutions.
• Develop individual protocols and data analysis plans and determine appropriate statistical methodology independently.
• Participate in database design meetings to ensure high‑quality data that satisfy analysis requirements.
• Collaborate with statistical programming staff to ensure all programs meet analysis requirements, internal SOPs, and external regulatory requirements.
• Evaluate software suitability for planned analyses and determine needs for potential program development of novel methodology.
• Analyze data and interpret results from clinical trials; apply basic and complex statistical techniques.
• Prepare oral and written reports to communicate trial results to project team, management, regulatory agencies, and investigators.
• Respond to queries on study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, and investigators.
• Plan and ensure accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participate in discussions with regulatory agencies and investigators concerning proposed or ongoing studies.
• Engage in research activities for innovative statistical methods and applications in clinical trial development.
• Mentor and guide junior staff in functional activities.

• PhD or equivalent in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or

• Master’s degree with a minimum of 6 years relevant work experience.

• Solid knowledge of statistical analysis methodologies and experimental design.
• Working knowledge of statistical and data processing software such as SAS and/or R.
• Good understanding of worldwide regulatory requirements and clinical trials expertise from Phase II to V.
• Strong oral and written communication skills; ability to function effectively in a team environment.
• Strong interest in statistical research activities and application of novel methods to clinical trial development.
• Ability to learn, be proactive, motivated, and consistently focus on details and execution.

• Publications in peer‑reviewed statistical/medical journals.
• Solid project management skills.
• Understanding of biology of disease and drug discovery and development.

US and Puerto Rico residents only.

Salary range: $ – $. Eligible for annual bonus and long‑term incentive, if applicable.

Comprehensive benefits package including medical, dental, vision, healthcare insurance for employee and family, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.

10%.

Domestic.

Not indicated.

Regular.

Yes.

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 applicable 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 personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC resources.

R401725

07/07/2026