Summary
About the Role
Key Responsibilities
- Lead statistical programming activities for several studies or drive the implementation of data analytics reports. Make decisions and propose strategies at study or project level.
- May act as functional manager for local associates including providing supervision and advice on functional expertise and processes.
- Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical aspects (timelines, scope, resource plan), e.g. as representative in study or project-level team.
- Ensure project-level standardization. Provide and implement programming solutions; ensure knowledge sharing.
- Act as expert in problem-solving aspects.
- Ensure timely and quality development and validation of datasets and outputs for regulatory submissions/interactions, safety reports, publications, post-marketing activities etc .Leads/co‐leads novel projects within the team -Generates innovative ideas within own team and /or project team /functional community
Essential Requirement
- Demonstrates strong proficiency in SAS for the analysis and summarization of clinical trial data.
- Has served as a Trial Programmer or in a comparable programming role with end‑to‑end study responsibility.
- Possesses experience in the development and/or review of critical study documents, including Protocols, eCRFs, Data Transfer Specifications, SAPs, and mock shells, ensuring consistency with study objectives and regulatory expectations.
- Shows openness to adopting R and other programming languages, with a willingness to embrace emerging technologies such as AI/ML.
- Exhibits a comprehensive understanding of CDISC data standards and their application across clinical studies.
- Minimum 5 years + with Graduation. (MSc preferred)
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
