Senior statistical programmer

2 days ago


Bengaluru, India ACL Digital Full time
Senior Statistical Programmer (6-8 years of exp)
LOOKING FOR IMMEDIATE JOINERS / SERVING NOTICE PERIOD
Location : CHENNAI / BANGALORE / HYDERABAD
Mode : Onsite
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 ADa M 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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