Position SummaryMBX is seeking an Associate Director, Statistical Programming to lead and contribute to statistical programming and analysis of clinical trial data. This role is integral to the design, execution, and interpretation of analyses for clinical trials and related research activities. The Associate Director will ensure the quality and accuracy of statistical deliverables, oversee external vendor performance, and contribute to internal process improvements, including maintaining and expanding SAS macros, R workflows, and clinical data repositories.
What You'll Do- Oversee and execute statistical programming deliverables for planned analyses, including study monitoring, data reviews, clinical study reports, data integrations, and rapid responses to regulatory queries across multiple compounds and studies.
- Lead global submission activities, acting as a programming functional and technical expert to support submission strategy planning and regulatory communications; ensure all programming deliverables meet timelines, quality standards, and regulatory expectations (eg, ICH, FDA, EMA).
- Manage CROs and contractors to ensure compliance, high-quality deliverables, adherence to timelines, and budget alignment.
- Develop and validate reproducible, well-documented statistical programs to produce outputs for integrated scientific reports of clinical trial results, ensuring adherence to protocols and Statistical Analysis Plans (SAPs), and regulatory reporting conventions.
- Maintain and enhance the internal SAS macro library and database.
- Provide statistical programming input for SAPs, publications, scientific presentations, regulatory submissions, and promotional materials.
- Review Case Report Forms (CRFs), CRF annotations, SAPs, Table, Listing, and Figure (TLF) shells, TLF outputs, dataset specifications (SDTM and ADaM).
- Serve as a lead for statistical programming within study teams, effectively communicating statistical and programming issues to development teams.
- Contribute to the development of programming standards, macros, SOPs, and process improvements within the Biometrics function
- Other responsibilities as assigned.
What You Bring- 8+years of statistical programming experience in the biotech or pharmaceutical industry, with a preference for expertise in endocrine and metabolic disorders.
- Advanced degree (PhD, MS, etc.) in life sciences, biostatistics, mathematics, computer science, or a related field preferred.
- Proficient in SAS programming (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) with a solid understanding of database systems
- Experience with R and Python preferred for advanced data visualization and analysis.
- Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and electronic submissions (eSub) under eCTD specifications.
- Proven ability to lead programming activities and provide oversight of CRO deliverables.
- Strong analytical, organizational, and communication skills, with a keen eye for detail and the ability to manage multiple priorities in a dynamic, fast-paced environment.
- Demonstrated leadership in cross-functional teams, experience with global submissions, and knowledge of database management.
Travel & In Office Presence You will be expected to travel periodically based on the needs of the business, including attendance at Together Weeks, Together Days, and functional meetings as requested by the team. Employees are expected to work on hybrid schedules, consistent with local office practices and the terms of the companies in office policy as in effect from time to time.
