Senior Clinical Statistical 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:

• The candidate should be technically sound and have hands-on experience in Statistical Programming.
• Responsible for appropriate code reviews and ensuring quality checks are performed on deliverables.
• Issues would be raised about timelines, deliverables, and quality directly, and he/she would be the key communicator in resolving problems at a team level.
• Providing support for onboarding additional programmers and mentoring them.

*Relevant industry experience is mandatory. Freshers may kindly refrain from applying.