Summary
Parexel is a global clinical development partner delivering clinical and consulting solutions for the life sciences industry. The Statistical Programmer II will develop and quality control SDTM datasets, support regulatory submissions, review SDTM mappings, and collaborate with sponsors and cross-functional teams. The role also supports programming improvements, project start-up activities, and SDTM Lead coordination in a remote clinical research environment.
Responsibilities
- Reviewing and providing feedback on Protocol and SAP related to SDTM mappings
- SDTM trial design domains development
- Complex SDTM datasets programming
- Simple to moderate macro debugging
- Solid SAS basic skills
- Support SDTM Lead
- Assist in coordination of project start-up activities
- Submission package preparation
- Understanding of efficacy endpoints and efficacy concepts (e.g., RECIST application, IMWG)
Skills
- * Bachelor's degree or Master's degree in Life Sciences, Computer Science, Pharmacy, or another relevant discipline, or equivalent experience
- * 3+ years of experience in SDTM statistical programming
- * Proficiency in SAS and knowledge of programming and reporting processes
- * Understanding of regulatory requirements and industry technical standards related to clinical trial data
- * Experience developing SDTM trial design domains and complex SDTM datasets
- * Excellent written and verbal communication skills, including competency in written English
- * Strong organizational, teamwork, and project management skills
- * Ability to adapt to changing priorities while supporting complex project deliverables
- * First degree (graduate or equivalent) in a relevant discipline
- * Experience supporting SDTM Leads on clinical research studies
Qualifications
Must Haves
- * Bachelor's degree or Master's degree in Life Sciences, Computer Science, Pharmacy, or another relevant discipline, or equivalent experience
- * 3+ years of experience in SDTM statistical programming
- * Proficiency in SAS and knowledge of programming and reporting processes
- * Understanding of regulatory requirements and industry technical standards related to clinical trial data
- * Experience developing SDTM trial design domains and complex SDTM datasets
- * Excellent written and verbal communication skills, including competency in written English
- * Strong organizational, teamwork, and project management skills
- * Ability to adapt to changing priorities while supporting complex project deliverables
Nice to Haves
- * First degree (graduate or equivalent) in a relevant discipline
- * Experience supporting SDTM Leads on clinical research studies
Benefits
- Remote work arrangement
- Continuous learning opportunities
- Career growth across statistical programming and clinical development