Senior Statistical Programmer, FSP

Job Description

Contribute to clinical trial data analysis and reporting by performing data manipulation using SAS programming. Generate and validate SDTM and ADaM datasets, analysis files, and TLFs. Develop complex ad-hoc reports and submission documents, while ensuring a strong understanding of Efficacy analysis. Collaborate with cross-functional teams, providing expertise and solutions for project specifications. Be adaptable, flexible, and a proactive team player to meet deadlines and achieve outstanding results.

Qualifications

1. Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field. 2. At least 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry with a Bachelor’s degree or equivalent, or 6 years with a Master’s degree or above. 3. Study lead experience, preferably managing multiple projects simultaneously. 4. Strong SAS data manipulation, analysis, and reporting skills. 5. Solid experience implementing the latest CDISC SDTM / ADaM standards. 6. Strong QC / validation skills. 7. Good ad-hoc reporting skills. 8. Proficiency in Efficacy analysis. 9. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. 10. Submissions experience utilizing define.xml and other submission documents. 11. Experience supporting immunology, respiratory or oncology studies is a plus. 12. Excellent analytical & troubleshooting skills. 13. Ability to provide quality output and deliverables within challenging timelines. 14. Ability to work effectively and successfully in a globally dispersed team environment.