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.
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.
Profile- 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).
Behavioral CompetenciesCuriosityContinue exploring new horizons. Constantly ask "Why?" and, more importantly, "Why not?"
CourageTake smart risks and support one another in continuously improving. Push boundaries, turn challenges into opportunities, and take ownership of our decisions, opinions, and actions.
CollaborationLearn from one another. Grow and develop as a multicultural, international team working toward shared goals.
CredibilityStrive for excellence in everything we do. Transparency and expertise are the foundation of our relationships with patients, partners, and shareholders. Data and results are at the heart of our commitment.
Department Medical Locations US - Warren, NJ Remote status Hybrid
