Strategic Lead Clinical Data Analyst

19 hours ago

mumbai, India beBeeStatistical Full time

Job DescriptionLead Statistical ProgrammerOversee and implement programming activities for Phase I-IV studies according to project strategies.Execute programming standards to support ongoing clinical studies, study reports, regulatory submissions, and ad-hoc/post-hoc analysis.Collaborate with internal stakeholders and external service providers to ensure timely and high-quality deliverables.Contribute to the development of standard macros, libraries, and processes as a team player.Key Roles and ResponsibilitiesLead statistical programming activities in therapeutic areas or compounds/indications within multiple studies/projects to ensure timely and high-quality deliverables.Develop and maintain programming documentations following programming standards and processes.Develop and oversee SAS programs for SDTM and ADaM datasets creation following CDISC standards and reports.Establish and maintain statistical programming standards, contribute to utility macro development, and participate in CRF annotation, SAP review, TLFs specifications development, and review.Handle P21-related items and eCRT packages for regulatory submission to health authorities.Support global regulatory authority submissions following guidelines and collaborate with partnering functions to address health authority requests.Demonstrate company values by showcasing excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Understand scope of work, plan deliveries and timelines with the study team, programming lead, and management.Perform end-to-end programming activities, act as a team player and SME, and focus on quality ensuring that programming deliverables meet regulatory submission requirements.Mentor and coach new hires and junior programmers requiring good collaborative skills.Qualification, Skills, and Competencies RequirementsMinimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in biotechnology, pharmaceutical, CRO, or healthcare industry.Oncology therapeutic area preferred.Strong SAS programming skills in clinical data environments with excellent analytical skills and working knowledge of other programming languages like R and Python.Excellent knowledge of pharmaceutical clinical development, understanding of statistical concepts, techniques, and clinical trial principles, and regulatory submissions.Extensive working knowledge of using and implementing CDISC standards, regulatory guidance, and TAUG.Ability to work independently and globally on interdisciplinary teams with strong organizational, interpersonal, and communication skills.Problem-solving and innovative skills demonstrating initiative and motivation.

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