Director – Biostatistics

Key Responsibilities

Statistical Leadership

• Provide strategic statistical oversight for Phase III clinical development programs and future lifecycle management activities.
• Lead the development of statistical strategies supporting clinical development plans, regulatory submissions, and post-hoc analyses.
• Serve as the statistical lead for one or more products and represent Biostatistics on cross-functional program teams.
• Advise senior management regarding statistical considerations, development risks, and mitigation strategies.

Clinical Trial Design & Analysis

• Lead the design and statistical methodology for Phase II, Phase III, and long-term extension studies.
• Author and review statistical sections of protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and submission documents.
• Ensure high-quality analysis of efficacy, safety, patient-reported outcomes, and biomarker data.
• Oversee endpoint selection, estimands, multiplicity strategies, interim analyses, and adaptive design considerations where appropriate.

Regulatory & Submission Support

• Lead the statistical components of NDA/BLA/MAA submissions, including integrated efficacy and safety analyses, statistical documentation, responses to agency questions, and preparation for regulatory review and inspection.
• Represent and defend statistical positions in interactions with global regulatory agencies, including FDA, EMA, MHRA, PMDA, and other health authorities.
• Support preparation of briefing packages, meeting materials, and responses to regulatory questions.
• Provide statistical leadership for NDA/BLA/MAA submission activities and inspection readiness.
• Ensure compliance with ICH, FDA, EMA, and other relevant regulatory guidance.

Vendor & Functional Oversight

• Manage and provide scientific and operational oversight of CROs, external biostatistics consultants, and statistical programming vendors.
• Collaborate closely with Statistical Programming to ensure analysis datasets, TLFs, and submission deliverables are generated according to CDISC standards.
• Review and approve key statistical deliverables to ensure quality, timelines, and regulatory compliance.

Cross-Functional Collaboration

• Partner with Clinical Development physicians, Clinical Operations, Data Management, Safety, and Regulatory Affairs to support program objectives.
• Present statistical findings to senior leadership, advisory boards, investigators, and external stakeholders.
• Mentor and develop junior statisticians and contribute to the growth of the Biometrics organization.

Qualifications

Education

• Ph.D. in Statistics, Biostatistics, Mathematics, or related quantitative discipline preferred.
• Master's degree with significant industry experience will be considered.

Experience

• 10+ years of biostatistical experience within the pharmaceutical, biotechnology, or CRO industry.
• Experience serving as lead statistician for late-stage clinical development programs.
• Demonstrated involvement in Phase III clinical trials and regulatory submissions.
• Experience supporting FDA and/or EMA interactions.
• Rare disease development experience strongly preferred.
• Prior experience in a small or emerging biotechnology environment is highly desirable.

Technical Skills

• Strong comprehensive knowledge of clinical trial methodology, statistical theory, and regulatory requirements.
• Expertise in ICH E9, estimands framework, adaptive trial designs, longitudinal data analysis, multiplicity methodologies, and missing data strategies.
• Working knowledge of CDISC SDTM and ADaM standards.
• Familiarity with SAS and R programming environments.
• Experience reviewing outputs, analyses, and submission deliverables generated by statistical programming teams.

Leadership Competencies

• Strategic thinker capable of balancing scientific rigor with business objectives.
• Strong communication and influencing skills across technical and non-technical stakeholders.
• Comfortable operating in a fast-paced, resource-conscious biotechnology environment.
• Demonstrated ability to manage multiple priorities while meeting aggressive development timelines.
• Collaborative, hands-on leader willing to work at both strategic and operational levels.

Preferred Experience

• Rare disease, orphan drug, or ultra-rare disease development programs, analysis of continuous glucose monitoring in applicable therapeutic areas.
• Experience supporting NDA, BLA, or MAA submissions.
• Exposure to accelerated approval pathways or breakthrough designation programs.
• Experience in a company transitioning from late-stage development to commercialization.
• Prior leadership of biometrics vendors and global development programs.