06 Sep
|
Novartis
|
Hyderabad
06 Sep
Novartis
Hyderabad
Job Description Summary
-Responsible for all statistical programming/data review reporting and analytics development aspects of several studies, a medium to large sized project or project-level activities. Acts as a key collaborator and strategic partner in ensuring that drug-development plans are executed efficiently with timely and high quality deliverables. Complies with project / study standards and specifications following internal and regulatory guidelines. Oversees programming style, quality of statistical reporting & compliance with timelines.
Job Description
Major Accountabilities:
- Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/ Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development.
- Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes.
Make statistical programming decisions/recommendations at study or project level.
- Build and maintain effective working relationships with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT).
- Review eCRF, discuss data structures, and participate in data review activities as member of the extended CTT.
- Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans.
- Provide and implement statistical programming solutions; ensure knowledge sharing. Understand Git-based version control workflows and their role in supporting team-oriented, traceable, and reproducible programming activities.
- In consultation with the Statistician, respon
📌 Principal Statistical Programmer (Hyderabad)
🏢 Novartis
📍 Hyderabad