Pharma - Clinical SAS - L10/9 - Mumbai

Responsibilities/Authorities

• Review and analysis of source (raw) data.
• Author mapping specifications from source (raw) data to target (CDISC SDTM and/or sponsor defined standards).
• Develop CDISC SDTM domains utilizing a data conversion tool.
• Quality Control of CDISC SDTM domains.
• Create data definition files and Case Report Forms annotated to CDISC SDTM.
• Assist with project status report and project related documentation.
• Proactively identify issues and contribute to solutions.
• Ensure quality for internal and external deliverables.
• Additional responsibilities as assigned or required.

Educational and Experience Requirements :

• Bachelors/Masters in computer science/life science with minimum of 1-3 years of relevant clinical and should have at least 1 year of SDTM experience.
• Demonstrated ability to produce CDISC SDTM, define.xml and controlled terminology complaint structures and knowledge of SQL, PL/SQL, packages is required.
• Clinical Data Management experience is an added advantage.
• Strong organizational, planning and problem solving skills, oral and written communication skills.