Job Description
Purpose: · Provide advanced technical expertise to develop and maintain programs/methodology to meet internal and external clientele needs. · Plan and lead the development of project-related solutions to the full scope of statistical programming tasks. · Provide technical expertise to the Statistical Programming department. Roles and Responsibilities: · Design or write program specifications based on consultations with Biostats · Write SAS codes to produce CDISC complaint datasets. · Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, adhocs and other clinical publications. · Write QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures and good programming practices. · Write programs for ISS, ISE and pooled datasets. · Revise programs for corrections, enhancements, or system environment changes. · Generate Pinnacle 21 reports, Define XML, Define PDFs, and Reviewers Guides. Review Pinnacle 21 report for action needed to fix errors and warnings.



· Assist in establishing standardized programming procedures and work instructions. · Develop, enhance, evaluate, and validate standardized macros and utility programs. · Ensure that regulatory requirements are met through validation/compliance activities. · Use and promote use of established standards, SOP and best practices. · Other responsibilities as assigned. Required Knowledge, Skills and Abilities: · Knowledge of statistics, programming and/or clinical drug development process · In-depth knowledge of applicable clinical research regulatory requirements, i.e., Positive Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines · Ability to implement programming specifications, as appropriate · Ability to estimate programming scope of work and assist in communicating project status · Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language · Exhibits routine and occ

📌 Lead Statistical Programmer (Mumbai)
🏢 Alten Calsoft Labs
📍 Mumbai