Hiring: Statistical Programmer – Clinical Data Analyst | SDTM, ADaM & TLF
Locations: Mumbai | Pune | Bangalore | Hyderabad | Delhi
Industry: Pharma / Biotech / Clinical Research
Experience: 5–12 Years
About the Role
Latinum HR is hiring a Statistical Programmer – Clinical Data for a leading Pharma/Biotech organization. This role plays a key part in supporting clinical trials, regulatory submissions, and integrated analyses while ensuring high-quality statistical programming deliverables across the drug development lifecycle.
Key Responsibilities
- Lead statistical programming activities for assigned compounds or therapeutic areas
- Create and validate ADaM datasets, TFLs in compliance with CDISC standards
- Develop and validate ISS and ISE for regulatory submissions
- Build, test, and maintain reusable SAS programs and macros
- Prepare reviewer guides, define.xml, and regulatory documentation
- Mentor and guide junior statistical programmers
- Collaborate closely with Biostatistics, CDM, Clinical, and Regulatory teams
Required Skills & Experience
- Strong hands-on experience in SAS programming (R experience is a plus)
- In-depth knowledge of CDISC standards (ADaM, SDTM & TFL)
- Experience supporting FDA / EMA regulatory submissions
- Understanding of clinical trial processes and data flow
- Exposure to therapeutic areas such as Oncology, Immunology, or Neuroscience
- Strong communication and leadership capabilities
Why Join Us
- Work on global, cutting-edge clinical trials
- Be part of a high-impact data-driven environment
- Collaborate with experienced professionals in life sciences
Interested candidates can share their CVs at:
[Confidential Information]
