Statistical Programmer- 5 Plus Years (Mumbai)

Role : Statistical Programmer Required skills : SAS, SDTM, ADaM, TLFs, Efficacy Domain Experience : 5 Plus Location : Remote Notice : Immediate to 30 days Job Purpose Serve as a leading role in statistical programming: provided high-level statistical programming support to a wide range of clinical trials as a consultant, both internal and external; make a significant contribution to the statistical programming standardization. The individual also serves as a pivotal role for process and project management. Job Responsibilities: - Robust 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 program .