Assoc Director, Statistical Programming

Job Description Summary

Responsible for all statistical programming/data review reporting & Analytics development aspects of one or more drug development projects or disease area. Direct, oversee and coordinate all activities, deliverables and resources within respective group or disease area. Ensure trials are conducted to a consistently high standard with respect to cost, quality and 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 -Recognizes and leverages innovation opportunities for own team across projects -Mentors and inspires others to solve problems -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Minimum Requirements:

• 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.
• 10 years' experience in SAS with Graduation min (MSc preferred)

 

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model