Senior Lead Statistician

1 week ago

Eluru, India beBeeStatistical Full time

Job DescriptionLead Statistical Programmer Role:As a key member of our programming team, you will be responsible for leading and executing statistical programming activities across multiple studies and projects.Develop and implement programming strategies to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Collaborate with internal stakeholders and external functional service providers to ensure timely and high-quality programming deliverables.Contribute to the development of standard macros, libraries, and processes, and act as a team player on various programming tasks.Key Responsibilities:Lead statistical programming activities for therapeutic areas or compounds/indications within multiple studies/projects.Develop and maintain programming documentations following programming standards and processes.Develop and oversee the development of SAS programs for creating SDTM and ADaM datasets following CDISC standards and reports.Participate in CRF annotation, SAP review, TLFs specifications development, and TLFs review.Handle P21-related items and eCRT package, including aCRF, define.XML, cSDRG, ADRG, and ARM, for regulatory submission to FDA/EMA/PMDA or other agencies.Requirements and QualificationsEducation and Experience:Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related discipline.7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO, or healthcare industry.Skills and Competencies:Strong SAS programming skills in a clinical data environment with excellent analytical skills.Working knowledge of other programming languages such as R, Python, etc.Great knowledge of pharmaceutical clinical development and regulatory submissions.Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance, and TAUG.

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