Associate Principal Scientist, Biostatistics

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, 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.

• Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. May interact with Contract Research Organization (CRO).
• This position may serve as a statistical lead in project teams.
• The incumbent may initially work in a specific disease area.

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.
• Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
• Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
• Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
• Participates in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements.
• Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our Company's Management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.
• Mentors and guides junior staff in functional activities.

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or a 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 e.g. SAS and/or R.
• Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Strong oral and written communication skills. Able to function effectively in a team environment.
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

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

US and Puerto Rico Residents Only.

Salary range: $ - $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. The company offers a comprehensive package of benefits that includes medical, dental, vision healthcare and other insurance benefits, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

Employee Status:
Regular. Relocation:
Domestic. Visa Sponsorship:
Yes. Travel Requirements: 10%. Flexible Work Arrangements:
Hybrid.