Senior Statistical Programming Manager
3 weeks ago
Senior Statistical Programming Manager
Location: Greater Boston, MA (Hybrid preferred) - Open to Remote (EST Only)
Salary: $150k-165k
Work Type: Prefered Hybrid (3 days in-office, 2 days remote)
GQR is seeking a Senior Statistical Programming Manager to oversee statistical programming activities across various studies and phases. The ideal candidate will be responsible for collaborating with cross-functional teams and managing relationships with external contract research organizations (CROs). This is an exciting opportunity for an experienced programming manager to thrive in a fast-paced environment and contribute to life-changing treatments.
Key Responsibilities:
- Lead all statistical programming activities for assigned studies, ensuring compliance with regulatory guidelines and timelines.
- Oversee CROs and other external vendors, ensuring high-quality and timely delivery of clinical data and statistical analyses.
- Collaborate cross-functionally to design and develop study documents, including SDTM and ADaM packages.
- Perform quality control for statistical programming deliverables, ensuring accuracy and completeness.
- Lead user acceptance testing for clinical databases and study data.
- Participate in ongoing data reviews and contribute to the preparation of clinical study reports.
- Ensure statistical programming compliance with regulatory requirements and industry best practices.
Qualifications:
- Master's degree or higher in Statistics, Mathematics, Computer Science, or a related field.
- Minimum of 5 years of statistical programming experience within the pharmaceutical industry or Biotech industry.
- Proficiency in SAS programming and development of SDTM, ADaM packages, and clinical study data analysis.
- Strong knowledge of regulatory guidelines, GCP, and clinical trial processes.
- Manage external vendor relationships.
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