Principal Stats Programmer

3 weeks ago

Mumbai, 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 notlimited 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 complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs

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 Covance 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 less-experience 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 ofstatistical programming

Experience (Minimum Required):Typically, 6 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Experience as lead statistical programmer on complex studies in clinical research.

Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management.

Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards

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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