Global Statistical Programming Lead

2 weeks ago

kottayam, India beBeeStatistical Full time

Job OverviewThe role of Global Statistical Programmer involves leading and executing programming activities for clinical studies. The ideal candidate will possess strong analytical skills, excellent knowledge of SAS programming in a clinical data environment, and the ability to work independently on global interdisciplinary teams.Key ResponsibilitiesLead statistical programming activities for multiple studies/projects within a therapeutic area or compound/indication to ensure timely and high-quality deliverables.Develop and maintain programming documentations following standard processes and CDISC guidelines.Oversee the development of SAS programs for SDTM and ADaM datasets, reports, and specifications.Contribute to the establishment and maintenance of statistical programming standards, macros, and libraries.Participate in CRF annotation, SAP review, TLFs specifications development, and TLFs review.Handle P21 related items and eCRT package components, including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions.Support global regulatory authority submissions by working closely with partnering functions and addressing health authority requests.Demonstrate company values through excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Perform end-to-end programming activities, act as a team player, and serve as a subject matter expert.Focus on timelines and quality to ensure programming deliverables meet regulatory submission requirements.Mentor and coach new hires and junior programmers, requiring good collaborative skills.Qualifications, Skills, and CompetenciesMinimum 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 with excellent analytical skills and working knowledge of other programming languages like R and Python.Great understanding of pharmaceutical clinical development, statistical concepts, techniques, and clinical trial principles, as well as regulatory submissions.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.Problem-solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills; SAS certificates are a plus. 3;What We OfferA dynamic and supportive work environment.Opportunities for professional growth and development.A chance to work on cutting-edge projects and contribute to the success of the organization.

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