Associate Director/Director, Statistical Programming
Structure Therapeutics
3 hours 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.