Director, Biostatistics
- Remote USA
- Employment Type: Permanent
- Required Therapeutic Area: NA
- Minimum office time: NA
Job Description
- Leads development and review of statistical deliverables including protocols (statistical sections), SAPS, TLFs, and CSR statistical content
- Ensures compliance with regulatory requirements, including ICH E9, GCP, and company SOPs
- Oversees biostatistics vendors and CROs, ensuring quality, consistency, and timeliness of deliverables
- Provides statistical input into study design including endpoints, estimands, sample size determination, and analysis methods
- Partners with Clinical, Data Management, Regulatory, and Medical Writing to ensure integrated execution and reporting
- Supports regulatory interactions and contributes to submission strategy
- Provides senior leadership with insights into study progress, risks, and interpretation of interim and final results
- Leads development and implementation of statistical standards and processes, including CDISC ADAM
- Contributes to integrated summaries (ISS/ISE), publications, and cross-study analyses
- Identifies statistical risks and develops mitigation strategies
- Leads inspection readiness activities related to statistical deliverables
- Plans and manages biostatistics resourcing and vendor strategy
Required / Preferred Experience, skills, and qualifications
- Advanced degree (MS or PhD) in Statistics, Biostatistics, Mathematics, or a related quantitative field
- Twelve (12) plus years of experience in the pharmaceutical industry with a minimum of four (4) years of experience in a managerial role
- Deep expertise in clinical trial design and statistical methodologies (Phase 1-3)
- Strong knowledge of regulatory expectations (ICH E9/E6, FDA/EMA MA interactions)
- Experience with estimands, adaptive designs, and modern statistical approaches
- Proficiency in SAS and/or R with understanding of statistical programming workflows
- Working knowledge of CDISC standards (ADAM) and submission requirements
- Ability to interpret complex data and translate into clear, actionable insights
- Proven leadership in vendor/CRO oversight and governance
- Strong cross-functional collaboration with Clinical, DM, Regulatory, and Medical Writing
- Demonstrated ability to influence strategy and decision-making at senior levels
- Excellent communication skills, including explaining statistical concepts to non-experts
Additional Details
The Director, Biostatistics leads the statistical design, analysis, and interpretation of clinical development programs to support decision-making and regulatory submissions. This role ensures robust, fit-for-purpose methodologies aligned with program objectives and regulatory expectations. The Director partners cross-functionally, oversees biostatistics vendors and CROs, and provides strategic statistical insights to inform development strategy and execution.
Clin Ops Solutions is an Equal Opportunity Employer. We believe diverse perspectives drive clinical innovation and welcome all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, or disability.