LEAD STATISTICAL PROGRAMMER

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, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
• Develop and/or validate SDTM domains, ADaM 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 P...