POSITION SUMMARY:We are seeking an experienced and strategic Senior director of Biostatistics to provide statistical leadership across oncology clinical development programs, with strong expertise in Phase 3 registrational studies, adaptive clinical trial design, and companion diagnostic (CDx) development. The successful candidate will play a critical role in advancing precision medicine strategies through innovative trial methodologies, biomarker-driven development, and global regulatory engagement.
This position requires extensive experience in oncology drug development, late-stage clinical trial strategy, adaptive designs, biomarker and CDx co-development, and regulatory submissions. The Senior Director will collaborate closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Affairs, Data Management, Statistical Programming, Clinical Operations, and external partners.
PRIMARY RESPONSIBILITIES AND DUTIES: - Clinical Development & Statistical Leadership
- Provide strategic statistical leadership for oncology programs from early development through registration and lifecycle management.
- Lead statistical design and execution of Phase 1-3 oncology clinical trials, with substantial emphasis on registrational Phase 3 studies.
- Develop innovative and efficient clinical trial designs, including:
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- Adaptive designs
- Biomarker-enrichment strategies
- Basket, umbrella, and platform trials
- Provide statistical guidance on:
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- Endpoint selection and Multiplicity control
- Estimand strategy
- Missing data methodology
- Sensitivity analyses
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- Clinical development plans
- Protocols
- Statistical analysis plans (SAPs)
- Clinical study reports (CSRs)
- Regulatory briefing packages
- Publications and scientific presentations
- Adaptive Design & Statistical Innovation
- Lead development and evaluation of adaptive design methodologies using simulation-based approaches.
- Conduct or oversee statistical simulations evaluating:
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- Operating characteristics
- Type I error control
- Statistical power
- Futility and efficacy boundaries
- Adaptive enrichment strategies
- Partner with programming teams to develop simulation frameworks in R and/or SAS.
- Communicate complex adaptive design concepts effectively to cross-functional teams and regulatory agencies.
- Regulatory & Submission Leadership
- Lead statistical support for:
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- End-of-Phase 2 meetings or Type B meetings
- Scientific advice meetings
- NDA/BLA submissions
- Provide strategic input on:
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- Alpha allocation/Multiplicity adjustment
- Interim/Final data analyses
- IDMC/DMC support
- Benefit-risk assessments
- Ensure compliance with ICH, FDA, EMA, and global regulatory guidance for both therapeutics and diagnostics.
- Cross-Functional & Organizational Leadership
- Function as a core member of oncology program teams
- Mentor and provide technical leadership to statisticians and programmers.
- Oversee CROs and external statistical vendors.
- Drive adoption of statistical standards, innovative methodologies, and data quality best practices.
- Support business development, due diligence, and portfolio strategy activities.
QUALIFICATIONS - PhD or MS in Biostatistics, Statistics, or related quantitative discipline.
- Typically:
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- PhD with 12+ years of biotechnology/pharmaceutical industry experience, or
- MS with 15+ years of industry experience.
- Extensive oncology drug development experience required.
- Demonstrated leadership in Phase 3 registrational oncology trials.
- Strong experience with adaptive clinical trial designs and simulation methodologies.
- Experience supporting companion diagnostic (CDx) co-development programs and biomarker-driven development strategies.
- Prior experience with global regulatory submissions and health authority interactions required.
- Biotech industry experience strongly preferred.
- Technical Expertise
- Strong knowledge of:
- Oncology clinical trial methodology
- Survival analysis and time-to-event endpoints
- Multiplicity adjustment and alpha control
- Group sequential and adaptive methodologies
- Bayesian and frequentist approaches
- Biomarker-driven clinical development
- Estimands framework
- Missing data methodology
- Interim monitoring and IDMC support
- Companion diagnostic statistical methodologies
- Proficiency in:
- SAS
- R
- EAST, ADDPLAN, or similar adaptive design software preferred
- Leadership Style
- Strategic and innovative thinker with strong scientific judgment
- Excellent communication and influencing skills
- Ability to explain complex statistical concepts to technical and non-technical stakeholders
- Strong collaboration and stakeholder management capabilities
- Proven ability to lead in a fast-paced biotechnology environment
Preferred Experience -
- Immuno-oncology and targeted therapy development
- Companion diagnostic (CDx) co-development and PMA support
- Precision medicine and biomarker-enriched development programs
- Global multi-regional clinical trials
- Accelerated approval pathways
SALARY RANGE: $240,000 - $280,000 DOE
PHYSICAL DEMANDS:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.
- Ability to communicate in written and oral forms.
- Must be able to interact and communicate in written and oral forms with a diverse group of individuals on both technical and business topics.
- The ability to sit, stand, kneel, stoop, walk, use hands to finger, handle, or feel, point, and reach with hands and arms.
- Must be able to travel 25% of the time without restriction, domestically and/or internationally.
- Must be able to use the telephone and communicate clearly with a host of external individuals, domestically and globally.
- Ability to work at a computer for extensive periods of time.
- Ability to work in a fast-paced working environment managing multiple tasks.
WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
