Senior Statistical Programmer

Senior Statistical Programmer

Your responsibilities:

- Lead and coordinate activities of all statistical programmers as Trial Programmer for phase I to IV clinical studies or assigned project-level activities. Make statistical programming recommendations at study level.

- Build and maintain effective working relationship with cross-functional teams, discuss status of deliverables and critical programming aspects (timelines, scope), e.g., as member of the Clinical Trial Team (CTT).

- Review eCRF, discuss data structures and participate in data review activities in accordance with the company, department, and industry standards (e.g., CDISC). Processes, review and develop programming specifications as part of the analysis plans.

- Provide input into statistical programming solutions and/or ensure their efficient implementation. Responsible for development of programming specifications of analysis datasets and pooled datasets.

- Ensuring timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.

- Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidelines. Contributes to assigned parts of process improvement, standardization, and other non-clinical initiatives.