Manager, Statistical Programming

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