Remote job
Associate Director, Statistical Programming
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About this role
Role overview
Lead statistical programming for clinical development programs, supporting study execution, regulatory submissions, and related analyses. The role combines hands-on programming expertise with oversight of external programming partners and close coordination with statisticians and cross-functional study teams. Work can be based at a Massachusetts hub or remote, with periodic in-person attendance at a hub.
Responsibilities - Lead programming for clinical studies and create or review specifications for accuracy, clarity, and compliance. - Direct ad hoc and post hoc analyses that address emerging study questions, publications, and internal decisions. - Coordinate external research organizations delivering CDISC-based SDTM and ADaM datasets and tables, figures, and listings. - Independently validate external programming outputs and conduct quality checks on datasets and statistical deliverables. - Partner with statisticians and study teams to deliver accurate results on schedule, managing priorities across multiple projects.
Requirements - Hands-on statistical programming experience in clinical development, preferably including leadership and late-phase trials. - Experience supporting regulatory filings such as NDAs or BLAs; experience with integrated safety and efficacy summaries is desirable. - Advanced SAS programming skills and thorough knowledge of CDISC standards. - Familiarity with ICH/GCP guidance and global submission expectations, including those of U.S. and European regulators. - Extensive experience overseeing external research organizations and validating their deliverables. - An MS in biostatistics, statistics, or a related field plus at least eight years of relevant experience, or a PhD plus at least six years.
Nice to have - Experience in cardiometabolic or a related therapeutic area.
Benefits and work setup - Hub-based option in Waltham, Massachusetts, with on-site work three to four days per week; remote option with one week at a hub every other month. - Listed compensation range is $159,000–$195,000 USD. Benefits include health coverage, flexible time off, paid holidays, year-end shutdown, wellness stipend, retirement matching, tuition support, commuter benefits, insurance, bonus opportunities, and equity grants.