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▷ (Urgent Search) Senior Statistical Programmer
4 days ago
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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Senior Statistical Programmer
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Senior Statistical Programmer
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1 week ago
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