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.