Senior Director, Biostatistics & Clinical Trials

Sagimet Biosciences; San Mateo (CA); On-site; USD 180,000 - 220,000; Full time

Job summary

Sagimet Biosciences seeks a Statistician to join its Clinical team in the San Mateo area. You will lead statistics across Phase II and III trials, guiding design, analysis, and reporting to meet regulatory standards.

You will develop SAPs, contribute to study protocols, and collaborate with CROs, data management, and regulatory affairs. Strong SAS/R and CDISC SDTM/ADaM expertise are required.

Qualifications

• Master's or PhD in statistics or biostatistics required; PhD strongly preferred.
• 7+ years in pharma/biotech with leadership on phase 2/3 programs.
• Experience with regulatory submissions (INDs/NDAs/BLAs).
• Proficient in SAS and R; CDISC SDTM/ADaM experience.

Responsibilities

• Lead statistician for Phase II/III trials from design to final reporting.
• Develop SAPs, randomization schemes, and sample size justifications.
• Create and oversee Tables, Listings, and Figures for reports.
• Collaborate with CROs and vendors; ensure QA of statistical work.
• Support regulatory submissions to FDA/EMA; assist with DSMB activities.

Skills

Statistical leadership

SAS

R

CDISC SDTM/ADaM

ICH E9 estimands

Regulatory submissions

Biostatistics communication

Education

M.S./Ph.D. in Statistics/Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Sagimet Biosciences seeks a Statistician to join its Clinical team in the San Mateo area. You will lead statistics across Phase II and III trials, guiding design, analysis, and reporting to meet regulatory standards.

You will develop SAPs, contribute to study protocols, and collaborate with CROs, data management, and regulatory affairs. Strong SAS/R and CDISC SDTM/ADaM expertise are required.