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4 days ago

kolkata, India beBeeStatistical Full time

Job Role Overview:This leadership position is responsible for overseeing and executing programming strategies across various studies, projects, and therapeutic areas.The successful candidate will lead cross-functional teams to deliver high-quality programming services, including the development of SDTM mapping specifications, ADaM datasets, and SAS programs. They will also ensure compliance with regulatory requirements and industry standards.Key ResponsibilitiesLead statistical programming activities, developing and implementing project strategies to meet business objectives.Collaborate with internal stakeholders and external partners to ensure timely and high-quality delivery of programming services.Develop and maintain documentation, following established processes and guidelines.Contribute to the development of standard macros, libraries, and processes.Participate in CRF annotation, SAP review, TLFs specifications development, and TLFs review.Handle P21 related items, eCRT package, aCRF, define.XML, cSDRG, ADRG, and ARM for regulatory submissions.RequirementsQualification, Skill and Competencies RequirementsMinimum Bachelor's degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related discipline with 7-8+ years of programming experience in processing clinical trial data in the biotechnology, pharmaceutical, CRO or health care related industry.Oncology Therapeutic area preferred.Strong SAS programming skills with excellent analytical skills. Working knowledge of other programming languages such as R, Python etc. is a plus.Extensive working knowledge of using and implementing CDISC standards, Regulatory guidance and TAUG. Prior PTL experience, attention to detail and ability to adapt to a fast-paced environment.Ability to work independently and on global interdisciplinary teams. Good organizational, interpersonal, and communication skills. Positive attitude, team player and growth mindset.Problem solving and innovative skills that demonstrate initiative and motivation.Demonstrated and applied SAS programming skills. SAS certificates a plus.

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