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Senior Statistical Programmer

10+ years
₹20 – ₹32 LPA
10 July 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Statistical Programmer – Clinical Reporting & CDISC

Location: [Not Specified]
Experience Required: 10+ Years
Job Type: Full-Time


Job Overview:
We are currently seeking an experienced Senior Statistical Programmer Analyst I (SR SPA I) to join our high-performance programming team. This is a critical role supporting statistical programming activities for regulatory submissions, statistical reporting, and clinical publications. You will work independently to lead programming efforts and interface with both client and internal cross-functional teams.


Key Responsibilities:

Statistical Programming & Data Management:

  • Independently develop and validate SAS code to support generation of analysis datasets (ADaM), statistical tables, listings, and figures (TLFs).

  • Perform SAS-based SDTM and ADaM mapping, data transformation, and delivery of submission-ready datasets.

  • Generate statistical outputs for Clinical Study Reports (CSRs) including CTRs, ISS, ISE, and other safety updates or publication needs.

  • Provide programming support for regulatory submissions, publications, and safety updates.

Technical Expertise:

  • Develop SAS applications and macros to streamline programming processes.

  • Validate programming deliverables to ensure accuracy and compliance with CDISC standards and client specifications.

  • Perform migrations, verifications, and troubleshoot programming issues across platforms.

Collaboration & Project Support:

  • Interface with Data Managers, Biostatisticians, Clinical teams, and external clients to understand project needs and ensure alignment.

  • Take ownership of deliverables, timelines, and act as subject matter expert (SME) in one or more key domains:

    • CDISC (SDTM/ADaM)

    • define.xml creation

    • Tables and graphical outputs

    • Pharmacokinetics / Pharmacodynamics (PK/PD)

    • Project Management and regulatory submissions


Desirable Skills and Experience:

  • 10+ years of experience in statistical programming within the pharmaceutical or CRO industry.

  • Strong knowledge and hands-on experience with SAS/Base, SAS/Macro, SAS/STAT.

  • Deep familiarity with CDISC standards, especially SDTM and ADaM.

  • Proficient in SAS programming across multiple platforms (Windows, UNIX).

  • Strong analytical background; statistics knowledge preferred.

  • Excellent problem-solving, communication, and documentation skills.

  • Ability to work independently while managing timelines and deliverables across multiple projects.


Estimated Salary: ₹20 – ₹32 LPA