Senior Statistical Programmer Lead

1 week ago

ghaziabad, India beBeeStatisticalLeader Full time

Job OverviewWe are seeking a seasoned professional to lead our statistical programming activities. This individual will be responsible for implementing and executing programming standards to support ongoing clinical studies and requests for study reports, regulatory submissions, and ad hoc/post hoc analysis.Lead multiple Phase I-IV studies programming activities as per project strategies.Work independently implementing and executing the programming and project standards to ensure timely and high-quality deliverables.Collaborate with internal stakeholders and external functional service providers to ensure all programming deliverables meet regulatory requirements.ResponsibilitiesDevelop and maintain programming documentations following established standards and processes.Create CDISC standard SDTM mapping specifications and ADaM specifications.Develop and oversee the development of SAS programs for dataset creation and report generation following CDISC standards.Contribute to the development of standard macros and participate in establishing statistical programming standards.Participate in CRF annotation, review of SAP, TLFs specifications development, and TLFs review.Handle P21 related items and eCRT packages for regulatory submissions.Support global regulatory authority submissions following guidelines and collaborate with partnering functions.Demonstrate company values through excellence, competence, collaboration, innovation, respect, ownership, teamwork, and accountability.Understand scope of work, plan deliveries, and timelines with study teams and management.Perform end-to-end programming activities and act as a team player and subject matter expert.Ensure quality and timelines align with regulatory submission requirements.Mentor and coach new hires and junior programmers, requiring good collaborative skills.RequirementsTo be successful in this role, you must possess:A minimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, or Life Sciences, with 7-8+ years of experience in clinical data processing.Oncology therapeutic area preferred.Strong SAS programming skills in a clinical environment with excellent analytical skills.Good knowledge of pharmaceutical clinical development and regulatory submissions.Experience with CDISC standards and implementation.Ability to work independently and collaboratively on global interdisciplinary teams.Excellent organizational, interpersonal, and communication skills.Positive attitude, team player, and growth mindset.

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