Senior Manager, Statistical Programming & Reporting

Job Description

Seeking a Senior Manager for Statistical Programming and Reporting to prepare clinical and statistical reports using SAS. Create tables, listings, and figures (TLFs) to support medical and clinical reviews in oncology clinical trials. Standardize basic reports for Risk-based Monitoring, addressing operational and data challenges. Collaborate with statisticians on abstracts, posters, and manuscripts. Implement CDISC, SDTM, and ADaM standards. Develop programs to validate analysis datasets and TLFs, ensuring compliance. Work on safety and efficacy analysis for oncology studies. Maintain SAS programming macros for data review, monitoring, reporting, and visualization.

Qualifications

1. Bachelor’s degree or foreign equivalent in pharmacy, statistics, or a related field. 2. Five (5) years of experience working in a statistical programming position for pharmaceutical or biotechnology clinical research and/or development. 3. Three (3) years of experience in: Creating SDTM/ADaM datasets while following CDISC standards; Creating Tables, Data Listings, and Figures (“TLFs”); Developing independent programs to validate analysis datasets and TLFs generated by vendor while ensuring compliance with CDISC and submission requirements; and Developing and maintaining SAS programming macros to support internal data review and monitoring. 4. Experience must also include two (2) years of experience working on oncology-related projects.