Director/Sr. Director Biostatistics
Structure Therapeutics
13 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
Provides biostatistics support for late-phase clinical studies, delivering strategic statistical input across feasibility, study design/methodology, analyses/interpretations, regulatory submissions (NDA/MAA/JNDA), and post-approval activities. Partners cross-functionally and may oversee internal programming staff or external consultants.
Responsibilities:
- Provide biostatistics support across the expanding portfolio.
- Review protocols; prepare statistical methods (endpoint selection, sample size, estimand/intercurrent events handling, Type I error control).
- Generate/review randomization schemas; review data collection strategies, database/edit checks, external data transfer, and SDTM mapping.
- Develop SAPs; create/review mock TLFs (tables/listings/figures), conduct analyses, and oversee TLF preparation for milestone readouts.
- Create/review programming specifications (SDTM/ADaM/TFL).
- Lead comment consolidation for SAPs and TLFs; lead unblinding and validate TLFs post database lock.
- Review study reports/manuscripts/regulatory documents; provide statistical leadership for marketing applications.
- Develop biostatistics SOPs/work instructions/guidelines/processes.
- Stay current on relevant scientific/statistical/AI advancements.
Requirements:
- PhD in Statistics/Biostatistics and 7–10 years clinical development/analysis/reporting experience.
- Strong clinical trial statistical design/analysis knowledge; experience with innovative study designs/methods.
- Interaction experience with FDA/EMA/PMDA and eCTD (NDA/BLA) submissions (preferred).
- CDISC knowledge (SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, Study Data Standardization Plan).
- Experience leading/optimizing biometrics processes (efficiency/quality).
- Strong clinical development knowledge across regulatory regions.
- SAS or R programming skills (strongly desirable).
- Excellent communication skills.
Preferred Experience:
- Track record of successive clinical trial designs/analyses and hands-on statistical analysis.
Travel:
- 5–10%.
Benefits (as stated):
- Medical, dental, and vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR.
Provides biostatistics support for late-phase clinical studies, delivering strategic statistical input across feasibility, study design/methodology, analyses/interpretations, regulatory submissions (NDA/MAA/JNDA), and post-approval activities. Partners cross-functionally and may oversee internal programming staff or external consultants.
Responsibilities:
- Provide biostatistics support across the expanding portfolio.
- Review protocols; prepare statistical methods (endpoint selection, sample size, estimand/intercurrent events handling, Type I error control).
- Generate/review randomization schemas; review data collection strategies, database/edit checks, external data transfer, and SDTM mapping.
- Develop SAPs; create/review mock TLFs (tables/listings/figures), conduct analyses, and oversee TLF preparation for milestone readouts.
- Create/review programming specifications (SDTM/ADaM/TFL).
- Lead comment consolidation for SAPs and TLFs; lead unblinding and validate TLFs post database lock.
- Review study reports/manuscripts/regulatory documents; provide statistical leadership for marketing applications.
- Develop biostatistics SOPs/work instructions/guidelines/processes.
- Stay current on relevant scientific/statistical/AI advancements.
Requirements:
- PhD in Statistics/Biostatistics and 7–10 years clinical development/analysis/reporting experience.
- Strong clinical trial statistical design/analysis knowledge; experience with innovative study designs/methods.
- Interaction experience with FDA/EMA/PMDA and eCTD (NDA/BLA) submissions (preferred).
- CDISC knowledge (SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules, Study Data Standardization Plan).
- Experience leading/optimizing biometrics processes (efficiency/quality).
- Strong clinical development knowledge across regulatory regions.
- SAS or R programming skills (strongly desirable).
- Excellent communication skills.
Preferred Experience:
- Track record of successive clinical trial designs/analyses and hands-on statistical analysis.
Travel:
- 5–10%.
Benefits (as stated):
- Medical, dental, and vision insurance; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
Application Instructions:
- Apply via the official career page at BambooHR.