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.