Principal Statistical Programmer

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 5 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