Principal Statistical Programmer

6 months ago

Bangalore, India MUM Fortrea Development India Pvt Ltd Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Perform the role of the Lead Statistical Programmer. Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc. Develop and maintain SAS programs to create SDTM datasets, ADaM datasets, generate tables, listings and figures and perform QC of SDTM, ADaMs and tables, listings, and figures. Produce Define XML/PDFs, Analysis Results Metadata (ARM), aCRF and Reviewers Guides to support SDTM and ADaMs Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to development of company and Client standards. Review SAPs and TFL shells from a programming perspective Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes. Present and share knowledge at department meetings. Respond to QA and client audits and support qualification audits. Contribute to proposal activities and participate in bid defenses meetings in order to win new business. Continually identify and suggest ways to improve the efficiency, quality, and productivity of statistical programming

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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