Senior Principal Statistical Programmer at Novartis · Hyderabad

Senior Principal Statistical Programmer Location: Hyderabad (Office) Job Description Summary 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 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 6 years + with Graduation. (MSc preferred) Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis