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Senior Principal Statistical Programmer

3 months ago

Mumbai, Maharashtra, India CSS Fortrea Scientific 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 a Lead Statistical Programmer including leading oversight of partnership
  • 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 complex 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 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

Qualifications (Minimum Required):

  • Bachelor science, or related subjects.Bachelor's degree, preferably in mathematics, statistics, computing, life science, health
  • Experience and/or education plus relevant work experience, equating to a Bachelor's degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirement

Experience (Minimum Required):

  • Typically, 8 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.
  • Extensive experience as lead statistical programmer on complex studies in clinical research.
  • Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including , 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.