Director, Biostatistics
About The Position
The Director, Biostatistics leads biostatistics activities for one or more Cardurion clinical studies. The role coordinates with statistical programming, pharmacometrics, data management colleagues, cross-functional teams, and external partners, providing statistical leadership to ensure Biometrics deliverables are accurate, timely, consistent, and completed to a high standard for regulatory success. The position leads statistical work across study design and development, including target product profiles, innovative study design, modelling and simulation, sample size calculations, and preparation of study documents and agency submissions. It also contributes to data monitoring and review, study reports, and publications; improves processes and evaluates biometrics tools; stays current with statistical methods and regulatory guidance; and provides technical guidance and mentorship to junior biostatisticians and external consultants.
Requirements
- PhD in Biostatistics or a related scientific discipline.
- At least 10 years of experience in biostatistics or a related area within the biopharmaceutical industry.
- At least 3 years of experience designing and implementing innovative trial designs.
- Experience conducting Phase 1–4 clinical trials and integrated analyses for NDA/BLA/MAA.
- Thorough understanding of and hands-on experience implementing CDISC standards.
- Proficiency in statistical programming software such as SAS or R to support analysis, review, and validation of statistical deliverables.
- Strong analytical and problem-solving skills, with expert knowledge of clinical trial design, statistical methodologies, and regulatory guidelines.
- Strong professional presence, focus and drive to succeed, confidence, passion, and high energy.
- Strong interpersonal communication skills to collaborate effectively with colleagues, stakeholders, and vendors.
Responsibilities
- Lead statistical activities for target product profiles, innovative study design, modelling and simulation, sample size calculation, and drafting of synopses, protocols, case report forms, statistical analysis plans, and agency-submission briefing books.
- Lead written and direct agency interactions.
- Coordinate with the broader biometrics team and external biometrics vendors to ensure deliverables are high quality, timely, and aligned with program objectives.
- Provide statistical input into data monitoring plans and data reviews for assigned studies.
- Review and contribute to final study reports and publications, ensuring appropriate statistical and data management procedures and interpretation.
- Identify opportunities to improve business processes and procedures to enhance speed, quality, efficiency, and output.
- Evaluate biometrics tools to meet program needs efficiently and effectively.
- Stay current on emerging statistical methodologies and regulatory guidance, including ICH E9/E9(R1), and apply relevant developments to study design and analysis strategy.
- Provide technical guidance and mentorship to junior biostatisticians and external consultants.
Benefits
- Blue Cross Blue Shield PPO
- Delta Dental
- VSP vision
- Fully funded HSA for the high-deductible PPO plan
- Traditional and Roth 401(k) with a 100% match on the first 4% deferred; match is immediately vested
- Company-paid life insurance
- Company-paid short-term and long-term disability insurance
- Flexible Spending Accounts for medical and dependent care expenses
- Four weeks of paid time off annually
- 11 company-paid holidays and a year-end shutdown
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
