Principal Clinical Data Programmer

Location : Bangalore / Mumbai / Remote (WFH)

Experience : 5+ years

Job Responsibilities :

• Strong oral and written communication skills
• Experience in handling complex efficacy domains and TFLs
• Act as subject matter expert for large-scale complex projects, providing hands-on support for the completion of projects. Solve critical technical problems.
• Participates in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM / ADAM specifications, datasets, and TLFs.
• Ensures excellence and high quality in the programming of analysis-ready datasets, tables, listings, and figures for which they are responsible.
• Provide support to mentor and train junior team members.
• Ensure all statistical activities are in accordance with internal and external quality standards, SOPs / WPDs, ICH-GCP, and / or other international / local regulatory requirements.
• Proficiency in SAS and CDISC for programming, as well as programming management skills for the project leader role.
• Experience in specialized therapeutic areas (TAs) such as oncology, immunology, and neurology would be a plus.

Core Strength :