Sr Mgr Statistical Programming

12 - 17 years

15 - 20 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Primarily works at the product / program level
  • Possible to have direct reports; Likely to oversee contingent workers and/or vendors; likely to provide training to others; Analyzes needs to manage resources. Mentor Jr Level programmers on the use of department standardization tools/processes.
  • Manages and Delivers assignments with quality and within timelines and provides input for budget planning
  • Independently develops, validates, and maintains complex programs and utilities in accordance with predefined specifications and standards.
  • Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros. Develop, debug, and enhance SAS (or any other Statistical software) programs to support quality control of safety or efficacy derived datasets.
  • Reviews key planning documents (e. g, Protocol, statistical analysis plan) to ensure alignment with project objectives, contributes to development of data presentation plan (DPP) , programming specifications (eg. SDTM, ADaM specs) , regulatory reviewers guide documents, ensures clarity and completeness of programming requirements, and robustness of assumptions.
  • Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource issues.
  • Responsible for the standardization of GSD deliverables across study projects within an indication/therapeutic area.
  • Contributes to the overall definition of programming rules and standardization across therapeutic areas and/or indication, including supporting visualization capabilities.
  • Identifies, supports process and technology improvement initiatives, communicates proactively and effectively around issues and risks and contributes to remediation strategies.
  • Leads global projects with cross-functional involvement; demonstrates project management and leadership capabilities.
  • Contributes to departmental policies, standards, and best practices.
Your experience and qualifications
  • Bachelor s Degree/Master s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
  • Bachelors + 12 year, Masters + 10 years in a pharmaceutical or clinical research setting as a programmer.
  • Expert level of programming skills and problem resolution in SAS or other Statistical programming software. Provide programming and documentation support for SAS (or other Statistical software) system development

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