Senior Statistical Programmer

3 weeks ago


India ACL Digital Full time

Senior Statistical Programmer (6-8 years of exp)

Location: Remote


ROLES and RESPONSIBILITIES:

  • Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
  • Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safetyand efficacy
  • Develop and/or validate Tables, Listings,and Figures using SAP and mock shells
  • Create or review P21 reports, define packages[Define.xml] and Reviewersguide [RGs] for CDISC Data Standards
  • Ability to work independently and as part of a team environment
  • Provide the status of assignedtasks to the Study Lead Programmer
  • Actively participating in the study meetings and support as backup lead
  • Identify, communicate, and manage study-based risks and issues within the timeframe
  • Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to the development of Statistical Programming standards and processesto improve the quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
  • Provide guidance, mentoring, and training for junior team members as appropriate


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