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., Valuable 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.
- Good 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 (Thiruvananthapuram)
🏢 ACL Digital
📍 Thiruvananthapuram