Position Summary
The position supports statistical programming for studies and regulatory submissions, ensuring high-quality, compliant deliverables aligned with CDISC standards and global regulatory requirements (e.g., FDA, EMA). The role maintains oversight of work performed by CROs, including review and verification of outputs to ensure accuracy and compliance; contributes to data review and cleaning; and advances internal programming capabilities through development of macros, processes, and automation to improve efficiency and consistency. Operating with a high degree of independence, they partner cross‑functionally to ensure high-quality, timely delivery of statistical programming outputs.
Essential Duties And Responsibilities
- Provides statistical programming support to Structure’s expanding portfolios
- Support and perform statistical programming for clinical studies and regulatory submissions
- Author and review SDRG, ADRG, and dataset specifications (SDTM and ADaM) to ensure compliance, traceability, and submission readiness
- Develop, validate, and maintain CDISC-compliant datasets (SDTM and ADaM) and analysis outputs (TFLs) using SAS (and/or R)
- Ensure timely delivery of high-quality, compliant deliverables aligned with CDISC standards and global regulatory requirements (e.g., FDA, EMA)
- Maintain oversight of work performed by CROs, including review and verification of outputs to ensure accuracy, quality, and compliance
- Perform hands‑on programming for complex analyses, ad hoc requests, and critical deliverables as needed
- Review study documents, including protocol, CRFs, SAP, DTS, and TFL shells
- Contribute to data review and cleaning activities to support data integrity and analysis readiness
- Collaborate cross‑functionally with Biostatistics, Data Management, Clinical Development, and Regulatory teams
- Develop and implement programming standards, macros, and automation to improve efficiency, consistency, and scalability
- Review datasets, TFLs, and define.xml to ensure quality and adherence to standards and specifications
- Support regulatory submissions, including preparation, validation, and response to health authority queries
- Identify and drive process improvements and best practices in statistical programming
- Operate with a high degree of independence to manage priorities and ensure timely, high-quality deliverables
- Perform other duties and responsibilities as assigned
Requirements
- Bachelor’s or master’s degree, in Statistics, Mathematics or other related discipline and at least 9 years Pharmaceutical/Biotech programming experience
- Excellent knowledge of CDISC submission requirements regarding SDTM, ADaM, Define.xml, Reviewers Guide and Validation Rules
- Demonstrated experience authoring and reviewing SDRG, ADRG, and dataset specifications (SDTM/ADaM)
- Ability to develop macros, utilities, and automation to improve programming efficiency
- Expert level SAS programming and management background along with solid knowledge and experience of SAS Programming language including SAS Base, SAS/Macros, SAS/Graph and SAS/Stat required
- Experience overseeing CRO programming activities, including review and verification of deliverables
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a small biotech setting
Preferred Experience
- Experience with global submissions (NDA, MAA, JNDA)
- Exposure to process improvement initiative and standardization efforts
- Ability to work in a fast‑paced, cross‑functional environment
Travel
5% travel required
Equal Opportunity Employer
Structure Therapeutics Inc. is an Equal-Opportunity Employer.
Compensation and Benefits
For this role, the anticipated base pay range is $180,000-$250,000. The base pay offered will depend on various factors, including geography, qualifications, skills, and experience. Base pay is only one part of the total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers medical, dental, vision insurance, 401(k) match, unlimited PTO, and paid holidays including a winter shutdown.
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