Senior Principal Statistical Programmer

3 weeks ago


Bengaluru, India Fortrea 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 a Lead Statistical Programmer including leading oversight of partnership programs. 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), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Fortrea and Client standards.
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective.
Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes.
Facilitate advanced technical expertise.
Respond to QA and client audits and represent the department in all types of audits.
Participate in partnership Bid Defenses in order to win new packages of 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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