Clinical Data Programming Lead

22 hours ago

salem, India beBeeStatistical Full time

Lead Statistical Programmer SpecialistJob Summary:Oversee multiple clinical studies programming activities to ensure timely and high-quality deliverables.Implement and execute the programming standards to support ongoing clinical studies, regulatory submissions, and ad hoc/post hoc analysis.Collaborate with internal stakeholders and external partners to deliver programming services in a fast-paced environment.Key Responsibilities:Develop and maintain detailed documentation of programming procedures following established standards.Create CDISC standard SDTM mapping specifications, ADaM specifications, and SAS programs for dataset creation.Contribute to the development of standard and utility macros, participate in establishing statistical programming standards.Participate in CRF annotation, SAP review, TLFs specification development, and review.Manage P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submission.Support global regulatory authority submissions and collaborate with partnering functions to address health authority requests.Ensure compliance with company policies and SOPs while working independently and on interdisciplinary teams.Provide training and mentorship to new hires and junior programmers, requiring strong communication skills.Focus on meeting timelines, quality, and regulatory requirements to ensure successful project delivery.Qualification and Competencies Requirements:Minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 7-8+ years of experience in clinical trial data processing.Strong SAS programming skills with analytical expertise. Working knowledge of R, Python is a plus.Therapeutic area expertise, pharmaceutical clinical development understanding, and regulatory submissions knowledge are essential.Ability to work independently, lead cross-functional teams, and exhibit excellent organizational and interpersonal skills.Problem-solving and innovative thinking abilities that demonstrate initiative and motivation.

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