Strategic Data Insights Leader

4 days ago

amravati, India beBeeStatistical Full time

Job Overview:We are seeking a skilled Global Lead Statistical Programmer to lead programming activities for clinical studies and projects. As a key member of our team, you will oversee the development of SAS programs, ensure high-quality deliverables, and contribute to the establishment of statistical programming standards.Responsibilities:Lead statistical programming activities for clinical studies and projects, ensuring timely and high-quality deliverablesDevelop and maintain programming documentation following industry standards and processesCreate CDISC standard SDTM mapping specifications and ADaM specificationsDevelop and oversee the development of SAS programs for data creation and reportingContribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standardsParticipate in CRF annotation, SAP review, TLFs specification development, and TLFs reviewHandle P21 related items, eCRT package, and regulatory submission tasksSupport global regulatory authority submissions, collaborating with partnering functionsDemonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountabilityPerform end-to-end programming activities, act as a team player, and SMEEnsure quality and timelines meet regulatory submission requirementsMentor and coach new hires and junior programmersRequirements:Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline7-8+ years of programming experience in processing clinical trial data in biotechnology, pharmaceutical, CRO, or health care related industryOncology therapeutic area preferredStrong SAS programming skills in a clinical data environment with excellent analytical skillsWorking knowledge of other programming languages such as R, Python etc. is a plusGreat knowledge of pharmaceutical clinical development and regulatory submissions (NDA, ANDA etc.)Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUGProblem solving and innovative skills that demonstrate initiative and motivationDemonstrated and applied SAS programming skills. SAS certificates a plus

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