6h ago
Associate Director, Statistical Programming
Burlington, MA
$195k-$225k / year
full-timelead Hybridbiotech
π Tech Stack
πΌ About This Role
You'll lead statistical programming activities supporting drug development programs and regulatory submissions. Your core impact is ensuring compliance with CDISC standards and timely delivery of high-quality programming outputs. This role offers a chance to drive efficiency through new tools and techniques.
π― What You'll Do
- Oversee SAS program development for SDTM, ADaM, and TLFs
- Ensure timely delivery for regulatory submissions and reports
- Lead programming activities and manage CRO partnerships
- Collaborate with biostatistics and clinical operations teams
π Requirements
- Master's degree in statistics, computer science, or related field
- At least 8 years of statistical programming experience in pharma/biotech
- Extensive experience leading statistical programming for clinical trials and submissions
- Excellent SAS programming skills and knowledge of CDISC standards
β¨ Nice to Have
- Knowledge of R and R Shiny
- Experience with FDA electronic data submission requirements
- Familiarity with ICH regulations
π Benefits & Perks
- π° Annual bonus opportunity
- π₯ Medical, dental, vision, life and AD&D insurance
- ποΈ Flexible non-accrual paid time off
- πΆ Parental leave
- π 401(K) plan with match and stock options
π¨ Hiring Process
Estimated timeline: 2-4 weeks Β· AI estimate
- 1Recruiter screenΒ· 30 min
- 2Hiring manager interviewΒ· 45 min
- 3Technical interviewΒ· 60 min
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