Senior Clinical Data Programmer Leader

2 weeks ago

mount, India beBeeStatistical Full time

Job DescriptionThe primary objective of this role is to lead the programming activities for one or more Phase I-IV studies in accordance with project strategies. This involves implementing and executing programming and project standards to support ongoing clinical studies, requests for study reports, regulatory submissions, and ad hoc/post hoc analyses.The successful candidate will work closely with internal stakeholders, external functional service providers, and other team members to ensure timely and high-quality deliverables. Key responsibilities include:Leading statistical programming activities for a therapeutic area or compound/indication within multiple studies/projects.Developing and maintaining programming documentations following programming standards and processes.Creating CDISC standard SDTM mapping specifications and ADaM specifications.Developing and overseeing the development of SAS programs for the creation of SDTM and ADaM datasets following CDISC standards and reports.Contributing to the development of standard and utility macros, participating in establishing and maintaining statistical programming standards.Participating in CRF annotation, review of SAP, TLFs specifications development and TLFs review.Handling all P21 related items and eCRT package including aCRF, define.XML, cSDRG, ADRG and ARM for regulatory submission to FDA/EMA/PMDA or other agencies.Supporting global regulatory authority submissions following guidelines (sdTCG, DSC, eCTD etc.) and working closely with partnering functions to address health authority requests.Required Skills and QualificationsThe ideal candidate will possess a strong background in statistics, computer science, mathematics, engineering, life sciences, or a related discipline. A minimum Bachelor's degree is required, along with 7-8+ years of experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO, or healthcare-related industry.Key qualifications include:Strong SAS programming skills in a clinical data environment with excellent analytical skills.Working knowledge of other programming languages such as R, Python, etc.Excellent knowledge of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles.Extensive working knowledge of using and implementing CDISC standards, regulatory guidance, and TAUG.Ability to work independently and on global interdisciplinary teams.Good organizational, interpersonal, and communication skills.BenefitsThe successful candidate will have the opportunity to work on exciting projects, develop new skills, and contribute to the growth and success of the organization.OthersThe ideal candidate will be a team player with a positive attitude, good problem-solving skills, and the ability to adapt to a fast-paced environment.

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