Associate Director/Director, Statistical Programming
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Support statistical programming for clinical studies and regulatory submissions, ensuring high-quality, compliant deliverables aligned with CDISC standards and global regulatory requirements (e.g., FDA, EMA). Maintain oversight of CRO outputs; contribute to data review/cleaning; and improve internal programming via macros, processes, and automation.
Essential Duties And Responsibilities
- Provide statistical programming support to expanding portfolios
- Author/review SDRG, ADRG, and dataset specifications (SDTM/ADaM)
- Develop/validate/maintain CDISC-compliant SDTM/ADaM datasets and analysis outputs (TFLs) using SAS (and/or R)
- Ensure timely delivery of compliant deliverables
- Review study documents (protocol, CRFs, SAP, DTS, TFL shells)
- Oversee CRO programming review/verification for accuracy and compliance
- Perform hands-on programming for complex analyses and critical deliverables
- Collaborate with Biostatistics, Data Management, Clinical Development, and Regulatory
- Develop/implement programming standards, macros, and automation
- Review datasets, TFLs, and define.xml for quality and adherence
- Support regulatory submissions, including validation and responses to health authority queries
- Identify and drive process improvements
Requirements
- BS/MS in Statistics, Mathematics, or related field + 9+ years pharmaceutical/biotech programming
- Expert knowledge of CDISC submission requirements (SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules)
- Experience authoring/reviewing SDRG/ADRG/dataset specs
- Ability to develop macros/utilities/automation
- Expert SAS programming (Base, Macros, Graph, Stat)
- Experience overseeing CRO programming
- Strong communication skills
Preferred
- Global submissions (NDA/MAA/JNDA); process improvement/standardization; fast-paced cross-functional work
Travel
- 5%
Benefits
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays incl. winter shutdown.
Application Instructions
- Apply via the company’s official career page at BambooHR.
Support statistical programming for clinical studies and regulatory submissions, ensuring high-quality, compliant deliverables aligned with CDISC standards and global regulatory requirements (e.g., FDA, EMA). Maintain oversight of CRO outputs; contribute to data review/cleaning; and improve internal programming via macros, processes, and automation.
Essential Duties And Responsibilities
- Provide statistical programming support to expanding portfolios
- Author/review SDRG, ADRG, and dataset specifications (SDTM/ADaM)
- Develop/validate/maintain CDISC-compliant SDTM/ADaM datasets and analysis outputs (TFLs) using SAS (and/or R)
- Ensure timely delivery of compliant deliverables
- Review study documents (protocol, CRFs, SAP, DTS, TFL shells)
- Oversee CRO programming review/verification for accuracy and compliance
- Perform hands-on programming for complex analyses and critical deliverables
- Collaborate with Biostatistics, Data Management, Clinical Development, and Regulatory
- Develop/implement programming standards, macros, and automation
- Review datasets, TFLs, and define.xml for quality and adherence
- Support regulatory submissions, including validation and responses to health authority queries
- Identify and drive process improvements
Requirements
- BS/MS in Statistics, Mathematics, or related field + 9+ years pharmaceutical/biotech programming
- Expert knowledge of CDISC submission requirements (SDTM, ADaM, Define.xml, Reviewers Guide, Validation Rules)
- Experience authoring/reviewing SDRG/ADRG/dataset specs
- Ability to develop macros/utilities/automation
- Expert SAS programming (Base, Macros, Graph, Stat)
- Experience overseeing CRO programming
- Strong communication skills
Preferred
- Global submissions (NDA/MAA/JNDA); process improvement/standardization; fast-paced cross-functional work
Travel
- 5%
Benefits
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays incl. winter shutdown.
Application Instructions
- Apply via the company’s official career page at BambooHR.