Statistical Programmer

Hiring:
Statistical Programmer – Clinical Data (SAS)

Locations:
Mumbai | Pune | Bangalore | Hyderabad | Delhi

Industry: Pharma / Biotech / Clinical Research

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Experience:

3–12 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)
- 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: