remote
Senior Scientist, Statistical Programming - Merck
Software Engineer
Senior Scientist in Statistical Programming leading SAS development of ADaM datasets and TFLs for clinical trial reports, ensuring compliance with CDISC, ICH, and regulatory standards for FDA/EMA submissions.
About the role
Key Responsibilities
- Develop and validate SAS programs to create ADaM datasets and TFLs for clinical study reports and regulatory submissions.
- Collaborate with biostatisticians, project leads, and stakeholders to ensure timely, high‑quality deliverables.
- Apply global CDISC, ICH, and therapeutic area standards to study and report programming.
- Maintain documentation and support regulatory review processes.
- Participate in project planning and execution to meet milestones.
Requirements
- Extensive experience in SAS programming for clinical trials.
- Proficiency in ADaM dataset creation and TFL generation.
- Strong knowledge of CDISC standards and ICH guidelines.
- Excellent communication and teamwork skills.
- Ability to work independently and manage multiple projects.
Skills
software developmentsystem designproblem solving