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Senior Clinical Programmer – Technical Lead - India

Job responsibilities

  • Responsible for implementation and execution of high quality clinical programming
  • Demonstrates strong understanding of ICH guidelines, as applicable to clinical programming
  • Creates programming training exercises, trains new programmers, and serves as mentor
  • Trains via self-study and self-practice independently and explores advanced topics related to clinical programming and/or drug development
  • Utilizes System Development Life Cycle (SDLC) for programming deliverables
  • Interacts directly and independently with client to coordinate all facets of the project; competent communicator
  • Works with statistical personnel to provide definitions, documentation and review of derived variables needed to produce planned tables, listings, and graphs
  • Generates tables, listings, and graphs from clinical trial databases using SAS
  • Develops programs, verifies, validates, and maintains clinical trial databases and data entry screen using SAS and related software
  • Develops data and programming specifications jointly with other programmers and biostatisticians
  • Designs specific data presentations including creative summary tables, graphs, and patient listings
  • Assists with preparing data validation plan based on client needs
  •  Develops clinical programming efficiencies based on broad, in-depth knowledge of procedures
  • Follows processes related to project management as appropriate for programming projects (e.g. updating Veo Project, updating PSS, close-out procedures etc)
  • Demonstrates extensive knowledge of departmental processes

Desired Skills and Experience

          Work from home option available

  • At least eight (6-8) years work experience in programming role, preferably supporting clinical trials/ or in the pharmaceutical industry)
  • Masters in Mathematics, Statistics/ Computer Science of Health Science graduates
  • Work from home available across India
  • Advanced knowledge of/ experience with SAS and other relevant programming software
  • Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs
  • Proven experience leading programmer support for multiple clinical trials and submission activities (or equivalent)
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP. ICH)
  • Strong experience with data and production of TLGs
  • Thorough understanding of CDISC standards and HL-7 standards
  • Experience in pharmaceutical or CRO industry
  • Proven experience in development of advanced MACROs with high programming efficiency;
  • Working knowledge of database design/ structures and basic statistics
  • Working experience in pooling analysis datasets across multiple clinical studies (or equivalent)
  • Familiarity with ISO 9001:2008 requirements
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