Principal Scientist, Biostatistics, Late-Stage Clinical Development
About The Position
The Principal Scientist, Biostatistics, works in BARDS (Biostatistics and Research Decision Sciences), a department within the Research and Development division. BARDS quantitative scientists partner with subject matter experts to apply scientific methodologies and tools supporting the discovery, development, regulatory approval, manufacturing, and marketing of medicines and vaccines. This role provides biostatistical leadership and support for late-stage clinical development projects and serves as a statistical lead on project teams. The incumbent may initially focus on a particular disease area, such as oncology. The position collaborates with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratories teams to design and analyze clinical trials and coordinate statistical activities. It may also involve interaction with academic and contract research organizations and external statistical consultants. The role may lead statisticians and statistical programmers, contribute to regulatory interactions, and mentor junior staff.
Requirements
- PhD or equivalent degree in statistics, biostatistics, or a related discipline with at least 6 years of relevant work experience; or a master's degree with at least 9 years of relevant work experience.
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills.
- Solid knowledge of statistical and data processing software, such as 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 and ability to function effectively in a team environment.
- Demonstrated interest in statistical research and applying novel methods to clinical trial development.
- Ability to learn, be proactive and motivated, and consistently focus on details and execution.
Nice To Haves
- Publications in peer-reviewed statistical or medical journals.
- Understanding of disease biology and drug discovery and development.
Responsibilities
- Serve as the statistical representative and lead on cross-functional teams for strategic planning and product development execution.
- Provide biostatistical leadership and support for drug and vaccine projects in late development.
- Contribute to clinical development planning, ensuring study designs align with program objectives and worldwide regulatory and marketing needs.
- Identify and anticipate technical and other potential problems in clinical trial design, conduct, and analysis, and propose and implement solutions.
- Develop protocols and data analysis plans, and determine appropriate statistical methodologies.
- Participate in database design meetings to ensure data quality and suitability for analysis.
- May lead statisticians and statistical programming staff to ensure programs meet analysis requirements, standard operating procedures, and regulatory requirements.
- Evaluate software for planned analyses and identify potential needs for developing novel statistical methodology.
- Analyze clinical trial data, interpret results, and apply basic and complex statistical techniques to meet study protocol objectives.
- Prepare oral and written reports communicating clinical trial results to project teams, company management, regulatory agencies, and investigators.
- Respond to queries about study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.
- May represent biostatistics in regulatory interactions, including presentations at advisory committee meetings.
- Plan and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participate with management in discussions with regulatory agency scientific personnel and investigators about proposed or ongoing studies.
- Conduct research on innovative statistical methods and applications in clinical trial development.
- Mentor and guide junior staff in functional activities.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
