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Statistical Programming Lead for Clinical Trials

1 month ago

Maidenhead, Windsor and Maidenhead, United Kingdom Lifelancer Full time

Discover a rewarding career as a Statistical Programming Lead for Clinical Trials at Fortrea, a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Our pharmaceutical, biotechnology, and medical device customers rely on us for innovative solutions across more than 20 therapeutic areas.

As a Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you will play a crucial role in the successful delivery of complex projects for a renowned, innovative, and global top pharmaceutical company. This position offers a unique opportunity to oversee studies from the Pharma side.

Your responsibilities will include liaising with the entire study team as needed, including Clinical, Medical Writing, Safety, and Biometrics. You may be involved in either in-house programmed or outsourced studies in either their Early or Late Phase team. This is a fantastic opportunity to gain insight into how Big Pharma operates while being part of a global CRO with opportunities for future career growth.

You will participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas.

This position allows you to work remotely from EMEA or choose to work from our local office in your home country.

What We Offer
  • A meaningful and challenging role in an established, diverse, highly profitable, and respected global company
  • A highly competitive compensation package, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, etc.
  • A genuine work-life balance
  • Flexibility in working hours
  • A thorough onboarding process with support from your personal mentor
  • A permanent employment contract with Fortrea
  • Excellent training and career development opportunities, as well as support with advancing your individual education
  • Strong support from your Line Manager and your team, as well as from over 19,000 Fortrea colleagues worldwide
Main Responsibilities:
  • 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, etc.
  • Oversee SDTM, ADaM, and TLF development, perform Senior Review of outputs
  • Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing, and additional development needs and analyses
  • Support/oversee submission activities (especially in late phase team)
  • Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
  • Mentor less-experienced team members in best practices around SDTMs, ADaMs, and TFLs while ensuring adherence to department standards and processes
Your Profile:
  • Ideal candidate: degree in mathematics, life sciences, statistics, computer sciences, etc.
  • In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO, or pharmaceutical company
  • Solid experience with complex clinical trials (minimum 5 years) and corresponding datasets content (safety and efficacy) and endpoints
  • Ideal knowledge of all aspects of clinical trials, from initial study setup to study completion, with understanding of roles and responsibilities of all related disciplines, e.g., Biostatistics and Clinical Data Management
  • Expert knowledge of base SAS, SAS macros, SAS/STAT, and debugging SAS programs
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guides, and submission standards
  • An autonomous, collaborative work style, a curious mind, and keen attention to detail
Compensation Package:

We offer a highly competitive salary range of $80,000 - $120,000 per annum, depending on your level of experience and qualifications.