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ProcDNA - Senior Statistical Programmer - R / SAS

ProcDNA - Senior Statistical Programmer - R / SAS

PROCDNA ANALYTICS PRIVATE LIMITEDPune
10 days ago
Job description

Position : Senior Statistical Programmer

Experience : 6+ Years

Job Type : Full-time

Key Responsibilities :

  • Leverage advanced proficiency in SAS and R programming to support or lead complex clinical studies, ensuring data integrity and quality.
  • Perform hands-on programming activities, including the creation of SDTM and ADaM datasets, as well as the generation of Tables, Listings, and Figures (TLFs) for both safety and efficacy analysis.
  • Take ownership of programming tasks with minimal supervision, demonstrating a deep understanding of the study's statistical analysis plan and data structures.
  • Lead all aspects of a clinical study under supervision, including coordination with data management, biostatistics, and clinical teams.
  • Create and maintain comprehensive documentation, including CRF annotations, dataset specifications (SDTM, ADaM, SDRG), and a define.xml for submission.
  • Identify gaps in current programming best practices and propose suggestions for improvement to enhance efficiency and compliance.
  • Ensure strict adherence to applicable policies, procedures, and evolving industry standards.
  • Take responsibility for the timely and accurate completion of all assigned development tasks, from initial programming to final submission.

Required Skills & Qualifications :

  • 6+ years of hands-on experience in SAS and R programming within a clinical trial environment.
  • Proven proficiency in CDISC standards, with practical experience in creating SDTM and ADaM datasets.
  • Hands-on experience with the generation of TLFs for both safety and efficacy analysis.
  • Experience with CRF annotations and the creation of dataset specifications.
  • Demonstrated ability to lead at least one clinical study under supervision.
  • A strong understanding of the clinical trial domain and the ability to apply this knowledge to programming activities.
  • The ability to execute a wide range of programming activities with minimal supervision.

    • Preferred Skills :

  • Experience with electronic submission processes (define.xml, P21, ADRG, SDRG).
  • Familiarity with other programming languages, such as Python, for data analysis.
  • Experience with SAS Grid or other high-performance computing environments.
  • Knowledge of statistical methodologies used in clinical trials.
  • Strong communication skills and the ability to work effectively in a team-based environment.

    • (ref : hirist.tech)

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