Global Lead Statistical Programmer

7 days ago

tiruppur, India beBeeStatisticalProgrammingLead Full time

Job TitleWe are seeking an experienced Statistical Programming Lead to join our team. As a Global Lead Statistical Programmer, you will be responsible for leading statistical programming activities across multiple projects and studies.This is a leadership role that requires strong technical skills, excellent communication and interpersonal skills, and the ability to work independently and as part of a global interdisciplinary team.Key ResponsibilitiesLead statistical programming activities for one or more 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.Develop and maintain programming documentations following programming standards and processes. Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports (Tables, Listings and Figures).Contribute to the development of standard and utility macros, participate in establishing and maintaining statistical programming standards.Participate in the 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 the regulatory submission to FDA/EMA/PMDA or other agencies.Support global regulatory authority submissions following the guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.Mentor and Coach new hires and junior programmers. Require good collaborative skills.Required Skills and QualificationsBachelor'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 health care 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.BenefitsThe opportunity to work on complex and challenging projects.The chance to develop your career in a dynamic and growing company.A competitive salary and benefits package.

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