Senior Statistical Programmer
2 weeks ago
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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