Senior Director, Statistics
About The Position
The Statistician will serve as a core member of Sagimet Biosciences' Clinical team, providing statistical expertise and leadership across Phase II and Phase III clinical trials. Reporting directly to the Chief Medical Officer, this individual will be responsible for the design, analysis, interpretation, and reporting of clinical study data in a manner that meets rigorous scientific and regulatory standards. This role will operate with a high degree of independence and versatility, collaborating cross-functionally with Clinical Operations, Regulatory Affairs, and external CROs and vendors. The position requires deep technical expertise in biostatistics, a thorough understanding of ICH/FDA/EMA guidelines, and the ability to communicate complex statistical concepts clearly to non-statistical stakeholders.
Requirements
- Master's degree (M.S.) or Ph.D. in Statistics, Biostatistics, or a closely related quantitative field required; Ph.D. strongly preferred.
- At least 7 years of statistical experience with a master's degree or 5 years with a Ph.D. in a pharmaceutical, biotech, or CRO environment, with demonstrated statistical leadership of Phase II and/or Phase III programs.
- Demonstrated experience supporting Phase II and/or Phase III clinical trials through regulatory submission.
- Proficiency in SAS (Base, STAT, GRAPH, MACRO) required.
- Experience with CDISC data standards (SDTM, ADaM) and regulatory submission packages.
- Strong working knowledge of ICH E9, the E9(R1) estimands framework, E6(R2) GCP, and FDA/EMA statistical guidance.
- Experience authoring or substantially contributing to SAPs, CSRs, and regulatory submission documents.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Nice To Haves
- Ph.D. in Statistics, Biostatistics, or a closely related quantitative field.
- Experience with R.
Responsibilities
- Serve as the lead statistician for Phase II and Phase III clinical trials, providing input throughout the full trial lifecycle from design through final reporting.
- Provide input and statistical oversight to outsourced Phase I clinical trials.
- Develop and author Statistical Analysis Plans (SAPs), randomization schemes, and sample size justifications for clinical studies.
- Partner with the CMO and Clinical Operations team to design study protocols, including endpoints, estimands, and statistical methodology sections.
- Perform and oversee statistical analyses using SAS and/or R, including primary, secondary, and exploratory analyses.
- Generate and validate Tables, Listings, and Figures (TLFs) for interim and final clinical study reports.
- Collaborate with CROs and external statistical vendors, providing oversight and quality review of contracted statistical work.
- Contribute to the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and briefing documents for FDA/EMA interactions.
- Support data review and database lock activities, including coordination with data management on CRF design, edit checks, and CDISC dataset standards (SDTM/ADaM).
- Ensure compliance with applicable regulatory guidelines, including ICH E9, E9(R1), E6(R2), and applicable FDA/EMA guidance documents.
- Develop and maintain programming code for reproducible analysis and submission-ready deliverables.
- Participate in Data Safety Monitoring Board (DSMB) activities, including providing blinded and unblinded statistical support as appropriate.
- Contribute to benefit-risk analyses and integrated summaries of safety and efficacy for regulatory filings.
- Support clinical development strategy by providing statistical input on trial design trade-offs, adaptive designs, and go/no-go decision frameworks.
- Present statistical methodology and findings to internal leadership, external partners, and regulatory agencies.
- Contribute to process improvements, SOPs, and best practices for statistical operations within the company.
- Provide cross-functional statistical support to Regulatory Affairs as needed.
- Maintain awareness of emerging statistical methods and regulatory trends to advance company capabilities.
- Assist with preparation of clinical development plans and integrated evidence packages.
- Support inspection readiness activities with respect to statistical documentation and audit trails.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
