Hiring For Biostatistical Programmer (SDTM & ADaM)

Job Title:

Experience:

About the Role

Biostatistical Programmer

Key Responsibilities

• Develop, validate, and maintain

  SDTM and ADaM datasets

  in compliance with

  CDISC standards

  and regulatory guidelines (FDA, PMDA, EMA).
• Program and validate

  tables, listings, and figures (TLFs)

  for clinical study reports and regulatory submissions.
• Ensure programming deliverables meet

  quality, timeline, and compliance

  standards.
• Collaborate with statisticians and clinical teams to translate analysis specifications into efficient programming solutions.
• Perform

  data quality checks

  and resolve issues in coordination with data management.
• Contribute to

  standardization efforts

  including macros, libraries, SOPs, and best practices.
• Support

  ad-hoc requests

  , exploratory analyses, and regulatory audits.

Required Skills & Qualifications

• Bachelor’s/Master’s degree in

  Biostatistics, Computer Science, Life Sciences

  , or related field.
• Strong programming skills in

  SAS (Base SAS, SAS/STAT, SAS/Macro)

  ,

  Python

  , and

  R

  .
• Hands-on experience with

  SDTM and ADaM dataset creation and validation

  .
• Solid understanding of

  CDISC standards

  and regulatory submission requirements.
• Knowledge of

  clinical trial processes

  ,

  ICH-GCP guidelines

  , and statistical concepts.
• Strong

  problem-solving

  , attention to detail, and documentation skills.
• Experience with

  Cloud environments

  like

  AWS

  and

  Azure

  .

Good to Have (Optional)

• Experience with

  Define.xml

  ,

  Pinnacle 21

  , and

  e-submission tools

  .
• Exposure to

  Life Sciences

  ,

  Pharma/Clinical Research

  , or

  CRO settings

  .
• Familiarity with

  safety and efficacy analysis

  in clinical trials.

How to Apply

Interested candidates can apply directly through Naukri or send their updated resume to shyamala.gunde@excelra.com