Job Description
LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)
LOCATION: ANYWHERE IN INDIA
WORK MODE - HYBRID
ROLES and RESPONSIBILITIES:
Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
Review Specifications, SDTM domains, ADa M datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
Develop and/or validate SDTM domains, ADa M datasets, and TLFs using SAP and mock shells
Setup the folder structure for the assigned study as per the SOP
Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
Provide the study status to the Project Manager/Client periodically
Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) t...
LOCATION: ANYWHERE IN INDIA
WORK MODE - HYBRID
ROLES and RESPONSIBILITIES:
Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
Review Specifications, SDTM domains, ADa M datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
Develop and/or validate SDTM domains, ADa M datasets, and TLFs using SAP and mock shells
Setup the folder structure for the assigned study as per the SOP
Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
Provide the study status to the Project Manager/Client periodically
Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) t...