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http://www.wipro.com

- Develop SAS programs for creation of SDTM and ADaM datasets, statistical analysis datasets, and Tables, Listings & Figures (TLFs).
- Perform independent validation of analysis datasets and statistical outputs.
- Support regulatory submission activities including Define.xml, reviewer guides, and e-submission package preparation.
- Review Statistical Analysis Plans (SAPs), data management plans, and other study documents to assess programming impacts and implementation strategies.
- Collaborate with internal teams, CROs, and vendors to ensure adherence to data standards and successful file transfers.
- Ensure high-quality deliverables that comply with regulatory requirements and company standards.
- Identify and implement process improvements to enhance efficiency, quality, and consistency.
- Lead programming assignments independently and provide technical guidance to team members.
- Contribute to standards development, automation initiatives, and continuous improvement projects.

Valuable-to-Have Skills

- 10+ years of Clinical/Statistical Programming experience.
- Experience supporting global regulatory submissions such as NDA, BLA, MAA,



and other health authority filings.
- Experience with R Programming for statistical analysis and data visualization.
- Working knowledge of Linux/Unix operating systems and shell scripting.
- Experience with programming automation and process optimization initiatives.
- Exposure to data visualization tools and advanced analytics platforms.
- Experience mentoring junior programmers and leading programming teams.
- Knowledge of industry-standard clinical development processes and submission standards.
- Experience working in global, multi-vendor, and multi-study environments.
- Familiarity with emerging technologies and tools used in statistical programming and clinical data

Must-Have Skills

- Bachelor's degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related discipline.
- 8+ years of Clinical SAS Programming experience within the pharmaceutical, biotechnology, or CRO industry.
- Strong expertise in Base SAS, SAS Macros, SAS/STAT, and advanced programming techniques.
- Hands-on experience in developing and validating SDTM and ADaM datasets.
- Strong knowledge of CDISC standards (SDTM, ADaM) and implementation best practices.
- Experience generating and validating Tables, Listings, and Figures (TLFs).
- Experience creating Define.xml, metadata documentation, and regulatory submission deliverables.
- Knowledge of regulatory requirements and guidelines from FDA, EMA, and ICH.
- Strong understanding of clinical trial processes, clinical endpoints, and medical terminology.
- Experience with upstream clinical data sources such as EDC systems and SDTM conversion processes.
- Proficiency in Pinnacle 21 for compliance reviews and data validation.
- Knowledge of XML and clinical data exchange standards.
- Understanding of relational databases and clinical data structures.
- Strong analytical, problem-solving, and debugging capabilities.
- Excellent communication, stakeholder management, and cross-functional collaboration skills.
- Ability to work independently and lead end-to-end programming activities.

📌 DATA ANALYST (Bengaluru)
🏢 Wipro
📍 Bengaluru