Senior Statistical Programmer (CDISC SDTM/ADaM)

Provide support for clinical studies through dual expertise in statistical programming compliant with CDISC standards (SDTM/ADaM) and applied biostatistics. The role includes the production, validation, and review of CDISC deliverables, as well as the execution and support of statistical analyses., * Participate in the design of clinical studies in collaboration with biostatisticians.

• Contribute to the writing and review of Statistical Analysis Plans (SAPs).
• Program and validate SDTM and ADaM datasets.
• Produce, validate, and review SDTM/ADaM deliverables (annotated CRFs, specifications, datasets).
• Ensure regulatory compliance using Pinnacle 21.
• Participate in and validate regulatory submission deliverables (Define.xml, submission packages).
• Perform Quality Control (QC) activities.
• Produce and validate Tables, Listings, and Figures (TLFs).
• Collaborate closely with clinical and regulatory teams.

• Master’s degree (MSc) or PhD in Biostatistics, Statistics, Mathematics, or a related field (e.g., ENSAI or equivalent).
• Minimum of 6-8 years of experience in statistical programming for clinical trials, with strong expertise in CDISC standards (SDTM/ADaM).
• Experience with regulatory submissions and CRO management is highly desirable.

Technical Skills

• Proficiency in SAS (Base SAS, SAS Studio, SAS Viya).
• Strong expertise in CDISC SDTM and ADaM standards.
• Good knowledge of TLFs (Tables, Listings, and Figures) and regulatory requirements.
• Experience using Pinnacle 21.
• Solid understanding of clinical statistics.
• Fluent English (written and spoken).