Data Analytics Leader

1 week ago

Tirupati, India beBeeStatistical Full time

Lead Statistical ProgrammerGrade: ManagerLocation: Hybrid at Gurugram/Mumbai. 100% Remote for the right candidate.Job Purpose:Direct programming activities for clinical studies as per project strategies.Implement and execute programming standards to support ongoing clinical studies and requests for study report, regulatory submission, and analysis.Collaborate with internal stakeholders and external service providers to ensure timely delivery of high-quality programming deliverables.Contribute to the development of standard macros, libraries, and processes.Key Roles and Responsibilities:Lead statistical programming activities for therapeutic areas or compounds/indications within multiple studies/projects.Develop and maintain programming documentation following programming standards and processes.Develop SAS programs for creating SDTM and ADaM datasets and reports following CDISC standards.Participate in establishing and maintaining statistical programming standards.Review CRF annotation, SAP, TLFs specifications, and TLFs review.Handle P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions.Support global regulatory authority submissions following guidelines and working closely with partnering functions to address health authority requests.Exhibit company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Understand scope of work, plan, and complete deliveries and timelines with study teams, programming leads, and management.Perform end-to-end programming activities and act as a team player and SME.Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Ensure all work is completed adhering to internal SOPs where applicable.Mentor and coach new hires and junior programmers requiring good collaborative skills.Qualification, Skill, and Competency Requirements:Minimum 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 the biotechnology, pharmaceutical, CRO, or healthcare industry.Oncology therapeutic area preferred.Strong SAS programming skills in a clinical data environment with excellent analytical skills.Good knowledge of other programming languages such as R, Python etc.Extensive working knowledge of using and implementing CDISC standards, regulatory guidance, and TAUG.Ability to work independently and on global interdisciplinary teams with good organizational, interpersonal, and communication skills.Positive attitude, team player, and growth mindset with problem-solving and innovative skills.Demonstrated and applied SAS programming skills.

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