Hiring For Biostatistical Programmer

3 days ago

Hyderabad, India Excelra Full time

Job Title: Biostatistical Programmer (SDTM & ADaM)

Experience: 5+ years
Employment Type: Full-time
Location: Hyderabad/Bangalore/Delhi/remote
Industry: Pharmaceuticals / Clinical Research / CRO
Functional Area: Biostatistics / Programming / Clinical Data Management

About the Role

We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM). This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory requirements.

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 , 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

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