Principal Scientist, Biostatistics, Late-Stage Clinical Development
About The Position
The Principal Scientist, Biostatistics, Late-Stage Clinical Development role is within BARDS (Biostatistics and Research Decision Sciences), part of the Research and Development division. The role provides statistical leadership and support for late-development drug and vaccine projects, working with cross-functional partners to design, conduct, analyze, and communicate clinical trials. The incumbent may initially support a particular disease area, such as oncology. The position contributes to strategic product-development planning and ensures study designs address program objectives and worldwide regulatory and marketing needs. It develops protocols and analysis plans, selects statistical methods, identifies and resolves potential trial issues, and supports high-quality data and analysis. The role also communicates trial results to project teams, management, regulators, and investigators; may participate in regulatory interactions; and contributes to statistical-method research while mentoring 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.
- Strong interest in statistical research and applying novel methods to clinical-trial development.
- Ability to learn, be proactive and motivated, and consistently focus on detail and execution.
- Required skills include clinical trials, data management, data science, scientific modeling, statistical analysis, and study design.
Nice To Haves
- Publications in peer-reviewed statistical or medical journals.
- Understanding of disease biology and drug discovery and development.
Responsibilities
- Serve as statistical lead and representative on project and cross-functional teams for product-development planning and execution.
- Provide biostatistical leadership and support for drug and vaccine projects in Late Development Statistics.
- Collaborate with Clinical, Regulatory, Statistical Programming, Data Management, Research Laboratories scientists, and potentially external research organizations and consultants.
- Contribute to clinical development planning and ensure study designs align with program objectives and worldwide regulatory and marketing needs.
- Anticipate technical and other potential problems in clinical-trial design, conduct, and analysis; propose and implement solutions.
- Develop protocols and data analysis plans, and independently 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, internal procedures, and regulatory requirements.
- Evaluate software for planned analyses and identify opportunities to develop novel statistical methods or programs.
- Analyze clinical-trial data and interpret results using basic and complex statistical techniques.
- Prepare oral and written reports communicating clinical-trial results to project teams, management, regulatory agencies, and investigators.
- Respond to queries concerning study design, analysis, and interpretation from clinical monitors, regulators, 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 in discussions with regulatory-agency scientific personnel and investigators about proposed or ongoing studies.
- Participate in research on innovative statistical methods and their application to clinical-trial development.
- Mentor and guide junior staff in functional activities.
Benefits
- Medical, dental, vision, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate 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
