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Senior Clinical Statistical Programmer (SDTM)

Senior Clinical Statistical Programmer (SDTM)

Tigermed India (Tigermed Clinical Research India Pvt Ltd)navi mumbai, maharashtra, in
7 days ago
Job description

Location : Bangalore / Mumbai / Remote (WFH)

Experience : 6.5+ years

Job Responsibilities :

  • Strong oral and written communication skills
  • Develop, map, and validate SDTM datasets (Study Data Tabulation Model) as per CDISC standards and regulatory requirements.
  • Perform Pinnacle 21 (P21) validation and resolve compliance issues for FDA / PMDA submissions.
  • Work with Real-World Data (RWD) to standardize and transform data into CDISC-compliant formats.
  • Worked with biomarker data, ensuring alignment with clinical datasets to support integrated analysis and interpretation.
  • Experienced in developing CDISC submission packages, including Define.xml, cSDRG, and ADRG documentation, ensuring compliance with regulatory standards.
  • Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM / ADAM specifications, datasets, and TLFs.
  • Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible.
  • Provide support to mentor and train junior team members.
  • Ensure all statistical activities are in accordance with internal and external quality standards, SOPs / WPDs, ICH-GCP, and / or other international / local regulatory requirements.
  • Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role.

Core Strength :

  • The candidate should be technically sound and have hands-on experience in Statistical Programming.
  • Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables.
  • Issues would be raised about timelines, deliverables, and quality directly, and he / she would be the key communicator in resolving problems at a team level.
  • Providing support for onboarding additional programmers and mentoring them.
  • Relevant industry experience is mandatory. Freshers may kindly refrain from applying.
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    Senior Statistical Programmer • navi mumbai, maharashtra, in

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