DATA ANALYST L4

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients’ most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting, design, engineering, and operations, we help clients realize their boldest ambitions and build future-ready, sustainable businesses. With nearly 245,000 employees and business partners across 65 countries, we deliver on the promise of helping our clients, colleagues, and communities thrive in an ever-changing world. Wipro is an Equal Employment Opportunity employer and makes all employment and employment-related decisions without regard to a person's race, sex, national origin, ancestry, disability, sexual orientation, or any other status protected by applicable law.

Website

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.

Good-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.