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 occasionally compl

📌 Lead Statistical Programmer (India)
🏢 ACL Digital
📍 India