Senior Manager Statistical Programming

Job Summary

A company is looking for a Senior Manager, Statistical Programming.

Key Responsibilities:

• Apply programming methodology to analyze clinical trial data and develop SAS programs for reporting purposes
• Review and approve programming specifications, datasets, and tables to ensure accuracy and adherence to regulatory standards
• Collaborate with internal and external stakeholders to define programming requirements and oversee outsourced programming activities

Required Qualifications:

• Bachelor's degree in a related scientific discipline or equivalent work experience
• At least 5 years of programming and/or data analysis experience in the pharmaceutical or biotechnology industry
• Subject matter expertise on CDISC data standards and experience with CDISC compliant data
• Experience with SDTM and ADaM lead roles in the pharmaceutical industry
• Thorough knowledge of regulatory requirements for data submissions and eSubmission guidelines