Strategic Leader: Clinical Data Analyst

2 weeks ago

moradabad, India beBeeStatisticalProgramming Full time

Job TitleLead Statistical Programmer - Pharmaceutical IndustryJob SummaryWe are seeking a highly skilled and experienced Lead Statistical Programmer to join our team. As a key member of the programming team, you will be responsible for leading statistical programming activities for multiple studies and projects in the pharmaceutical industry.About the RoleLeads statistical programming activities for therapeutic areas or compounds/indications within multiple studies/projects in various study activities to ensure timely and high-quality programming deliverables in assigned projects and areas.Develops and maintains programming documentations following programming standards and processes. Creates CDISC standard SDTM mapping specifications and ADaM specifications.Develops and oversees the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).Contributes to the development of standard and utility macros, participates in establishing and maintaining statistical programming standards.Participates in the CRF annotation, review of SAP, TLFs specifications development and TLFs review.Handles all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for the regulatory submission to FDA/EMA/PMDA or other agencies.Supports global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.Demonstrates company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.Understands the scope of work, plans and completes the deliveries and timelines with the study team, programming lead and management.Performs end-to-end programming activities, acts as a team player and SME.Focusing on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Ensures all work is completed adhering to the internal SOPs where applicable.Mentors and coaches new hires and junior programmers. Requires good collaborative skills.RequirementsMinimum 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-related industry.Oncology Therapeutic area preferred.Strong SAS programming skills in a clinical data environment with excellent analytical skills. Working knowledge of other programming languages such as R, Python etc. is a plus.Great knowledge of pharmaceutical clinical development (i.e., understanding of statistical concepts, techniques, and clinical trial principles) and regulatory submissions (NDA, ANDA etc.).Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and able to adapt to a fast-paced environment.Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.Problem-solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills. SAS certificates a plus.Statistical Programming

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