Principal Statistical Researcher

4 days ago

kakinada, India beBeeClinical Full time

Senior Lead Clinical Data ProgrammerAbout the RoleWe are seeking an experienced Senior Lead Clinical Data Programmer to lead our clinical data programming activities.Key Responsibilities:Lead multiple phase I-IV studies programming activities as per project strategies.Implement and execute programming standards to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Collaborate with internal stakeholders, external functional service providers, and global teams to ensure timely and high-quality programming deliverables.Develop and maintain documentation following programming standards and processes.Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee SAS programs for creating SDTM and ADaM datasets following CDISC standards and reports.Contribute to establishing and maintaining statistical programming standards.Participate in CRF annotation, review of SAP, TLFs specifications development, and TLFs review.Handle all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following guidelines (sdTCG, DSC, eCTD etc.) and work closely with partnering functions to address health authority requests.Requirements: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-related industry.Oncology therapeutic area preferred.Strong SAS programming skills in a clinical data environment with excellent analytical skills.Knowledge of pharmaceutical clinical development and regulatory submissions (NDA, ANDA etc.).Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance, and TAUG.Ability to work independently and on global interdisciplinary teams.Good organizational, interpersonal, and communication skills.Bonus Requirements:SAS certificates a plus.Problem-solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills.Benefits:Opportunity to work on complex clinical trials projects.Professional growth and development opportunities.A collaborative and dynamic work environment.

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