Senior Data Science Lead

1 day ago

anand, India beBeeStatistical Full time

Job DescriptionLead Statistical Programmer to lead programming activities for our clinical studies and projects. You will be responsible for implementing and executing programming standards, ensuring timely and high-quality deliverables.Key ResponsibilitiesLead statistical programming activities for multiple studies/projects in various therapeutic areas, ensuring timely and high-quality deliverables.Develop and maintain programming documentations following CDISC standards and processes.Develop 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 regulatory submission.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 the scope of work, plan and complete deliveries and timelines with the study team, programming lead and management.Required Skills and Qualifications To succeed in this role, you will need:Qualification, Skill and Competencies RequirementsMinimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline.7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or healthcare related industry.Strong SAS programming skills in a clinical data environment with excellent analytical skills.Good knowledge of pharmaceutical clinical development and regulatory submissions.Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG.Ability to work independently and on global interdisciplinary teams.Problem solving and innovative skills that demonstrate initiative and motivation.

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