About this role
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.