Senior Statistical Programmer
- ACL Digital
- 5 - 10 years
- Hyderabad
- 1 month ago
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Job Description
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 Safety and efficacy
Develop and/or validate Tables, Listings, and Figures using SAP and mock shells
Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards
Ability to work independently and as part of a team environment
Provide the status of assigned tasks 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 processes to 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
Job Classification
Industry: Clinical Research / Contract ResearchFunctional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Clinical research Scientist
Employement Type: Full time
Contact Details:
Company: ACL DigitalLocation(s): Hyderabad
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