Program Director

2 weeks ago

alwar, India beBeeStatistical Full time

Senior Statistical Programming LeadThe role involves leading one or more Phase I-IV studies programming activities as per the project strategies.Implement and execute the programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.Collaborate with internal partnering functions, stakeholders, and external functional service providers to ensure all the programming deliverables are delivered in a timely manner with high quality.Participate in contributing to development of standard macros, libraries, processes and act as a team player on the various programming tasks.The responsibilities include:Lead statistical programming activities for a therapeutic area or compound/indication 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 CRF annotation, review of SAP, TLFs specifications development and TLFs review.Handle 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 guidelines and working closely with partnering functions to address health authority requests.Develop effective collaboration and communication skills to work effectively with cross-functional teams and stakeholders.Key Responsibilities:Oversee the development of complex statistical models and lead the implementation of data management and reporting solutions.Develop and implement data validation procedures and report any discrepancies.Review and provide feedback on submitted documents and reports.Identify and prioritize opportunities for process improvements and implement changes.Requirements:Advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, or related field.Minimum 7 years of experience in clinical trials programming with expertise in SAS programming language.Strong knowledge of clinical trial regulations and guidelines such as GCP, ICH, and FDA/EMA requirements.Ability to work independently and collaboratively as part of a cross-functional team.Effective communication and presentation skills.

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