Senior Statistical Programmer (CDISC SDTM/ADaM)

Responsibilities:
- 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.

Qualifications:
- MSc or PhD in Biostatistics, Statistics, Mathematics, or related field (e.g., ENSAI or equivalent).
- Minimum 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 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 and regulatory requirements.
- Experience using Pinnacle 21.
- Solid understanding of clinical statistics.
- Fluent English (written and spoken).