Hiring For Biostatistical Programmer (sdtm & Adam)
- Excelra
- 5 - 10 years
- Hyderabad
- 4 months ago
- Email to a friend
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Job Description
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
- Bachelors/Masters 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 sh***********e@ex****a.com
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Pharmaceutical & BiotechnologyRole: Pharmaceutical & Biotechnology - OtherEmployement Type: Full timeContact Details:
Company: ExcelraLocation(s): Hyderabad
Keyskills: Adam Cdisc SAS Programming Sdtm Python FDA R ICH-GCP Guidelines EMA PMDA
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