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., Good 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 complex problem-solving skills · Recognizes when negotiating skills are needed and seeks assistance. · Good organizational, interpersonal, leadership and communication skills · Ability to effectively handle multiple tasks and projects, under supervision · Excellent accuracy and attention to detail · Ability to establish and maintain effective working relationships with co-workers, managers, and clients

Minimum Education and Experience: · Masters degree in computer science, statistics or related field; Bachelor's degree in computer science, statistics or equivalent combination of education, training and experience. · SAS certification preferred but not required. · R programming knowledge preferred but not required. · Strong knowledge of CDISC SDTM and ADaM standards. · Positive understanding of GCP regulatory requirements and drug development process. · Excellent organizational skills and good verbal and written communication skills. · Ability to work independently.

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