Manager, Statistical Programming
Genmab
Full-time
Remote friendly (Plainsboro, NJ)
United States
$112,960 - $169,440 USD yearly
Clinical Research and Development
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Role Summary
Manager, Statistical Programming – Hands-on support of clinical trial reporting; Leading a team of programmers to complete trial or compound level programming activities.
Responsibilities
- Review and input into key study level documents including CRF, SAP, table shells
- Drive development of ADaM specifications in accordance with CDISC and Genmab standards
- Develop programs to create ADaM and TLF for individual studies or integrated efforts
- Provide sponsor oversight of vendor programming activities and/or perform QC of in-house deliverables including ADaM, TLF, and submission packages
- Act as SME contributing to improvement of departmental processes, standards, and templates
Qualifications
- Required: Bachelor's degree or equivalent qualification, and fully trained in SAS
- Required: 4+ years of experience in relevant area
- Required: Experience using SAS software package
- Preferred: Oncology experience
- Preferred: Previous experience as a trial lead
- Preferred: R experience
- Notes: This position does not have direct reports
Skills
- Statistical programming for clinical trials
- ADaM and table generation (TLF)
- Vendor management and QC
- Process improvement and standardization
Education
- Bachelor's degree or equivalent qualification
Additional Requirements
- Location and travel: US-based candidate considerations; no explicit travel requirements stated