Offer summary
Qualifications:
Bachelor's or master's degree in biostatistics, computer science, or related fields., At least 6 years of relevant experience in the biotech or pharmaceutical industry., Proficient in SAS programming in a regulated clinical research environment..
Key responsabilities:
- Generate SDTM and ADaM datasets, tables, listings, and figures for studies and regulatory agencies.
- Review statistical analysis plans, CRFs, and study data-related documents.
- Contribute to study reports, regulatory submissions, safety update reports.
- Perform additional analysis/validation, collaborate with CRO statisticians.
- Contribute to Biometrics SOPs, process improvement initiatives, and department infrastructure.