Senior Lead Statistician

1 day ago

ajmer, India beBeeStatistical Full time

Job Title: Global Lead Statistical ProgrammerJob Description:The incumbent will lead one or more Phase I-IV studies programming activities as per project strategies, implementing and executing programming and project standards to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis.Key Responsibilities:Oversee 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 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 guidelines and working closely with partnering functions to address health authority requests.Demonstrate company values by demonstrating excellence, competence, collaboration, innovation, respect, ownership, team work and accountability.Understand scope of work, plan and complete deliveries and timelines with study team, programming lead and management.Perform end-to-end programming activities, act as a team player and SME.Focus on timelines and quality ensuring that programming deliverables meet regulatory submission requirements.Ensure all work is completed adhering to internal SOPs where applicable.Mentor and Coach new hires and junior programmers. Require good collaborative skills.Required Skills and Qualifications:Strong knowledge of programming principles and software applications such as SAS.Proficiency in data analysis and interpretation.Excellent communication and interpersonal skills.Ability to work effectively in a team environment.Flexibility and adaptability to changing priorities and deadlines.Benefits:Opportunity to work with a talented team of professionals.Professional growth and development opportunities.Collaborative and dynamic work environment.Others:Good understanding of global regulatory requirements.High level of integrity and professionalism.

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