Associate Director, Biostatistics
4D Molecular Therapeutics
August 21, 2026
Remote friendly (United States)
United States
Clinical Research and Development
General Summary
The Associate Director, Biostatistics provides strategic input and technical expertise on statistical methodology to lead assigned projects as part of a cross-functional team, collaborating with internal stakeholders and external vendors.
Major Duties & Responsibilities:
- Provide statistical expertise on study design/planning, protocol development, and statistical methodology/analysis.
- Develop statistical analysis plans (SAP), TFL shells, and other analysis specifications.
- Develop randomization schema for assigned randomized studies.
- Perform data analysis and/or collaborate with statistical programming (in-house or vendor) to ensure analyses meet the SAP/specifications.
- Develop statistical reports summarizing analysis results.
- Ensure accurate interpretation and consistent/accurate data presentation for study reports and publications.
- Collaborate to ensure robust CRF/EDC development and quality data collection.
- Perform quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate review comments.
- Stay current on industry developments in biostatistics/statistical programming and apply as appropriate.
Qualifications:
- Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience.
- M.S. with 7+ years or PhD with 4+ years in biotech/pharmaceutical industry.
- Experience in ophthalmology and/or biologic/gene therapy (preferred/a plus).
- Experience across clinical phases I–IV (desirable).
Required/Preferred Skills:
- Knowledge of clinical trial standards: CDISC, SDTM, ADaM, MedDRA, WHODRUG.
- Knowledge of GCP/FDACHMP/ICH/HIPPA regulations.
- Strong organization/time management, attention to detail, and ability to multitask in a fast-paced environment.
- Excellent written/verbal communication and cross-functional teamwork.
Travel: <5%
The Associate Director, Biostatistics provides strategic input and technical expertise on statistical methodology to lead assigned projects as part of a cross-functional team, collaborating with internal stakeholders and external vendors.
Major Duties & Responsibilities:
- Provide statistical expertise on study design/planning, protocol development, and statistical methodology/analysis.
- Develop statistical analysis plans (SAP), TFL shells, and other analysis specifications.
- Develop randomization schema for assigned randomized studies.
- Perform data analysis and/or collaborate with statistical programming (in-house or vendor) to ensure analyses meet the SAP/specifications.
- Develop statistical reports summarizing analysis results.
- Ensure accurate interpretation and consistent/accurate data presentation for study reports and publications.
- Collaborate to ensure robust CRF/EDC development and quality data collection.
- Perform quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate review comments.
- Stay current on industry developments in biostatistics/statistical programming and apply as appropriate.
Qualifications:
- Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience.
- M.S. with 7+ years or PhD with 4+ years in biotech/pharmaceutical industry.
- Experience in ophthalmology and/or biologic/gene therapy (preferred/a plus).
- Experience across clinical phases I–IV (desirable).
Required/Preferred Skills:
- Knowledge of clinical trial standards: CDISC, SDTM, ADaM, MedDRA, WHODRUG.
- Knowledge of GCP/FDACHMP/ICH/HIPPA regulations.
- Strong organization/time management, attention to detail, and ability to multitask in a fast-paced environment.
- Excellent written/verbal communication and cross-functional teamwork.
Travel: <5%