Lead Statistical SAS Programmer, Oncology, Single Sponsor

4 weeks ago

Copenhagen, Copenhagen, Denmark MAI Fortrea Development Limited Full time
About the Role

As a leading global contract research organization (CRO), Fortrea is committed to delivering high-quality clinical development solutions to pharmaceutical, biotechnology, and medical device customers. We are seeking an experienced Lead Statistical SAS Programmer to join our team in Oncology.

Key Responsibilities
  • Plan, execute, and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interaction with other departments.
  • 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.
Requirements
  • Ideal degree in a relevant field such as 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 oncology clinical trials (minimum 5 years) and the corresponding datasets' content (safety and efficacy) and endpoints.
  • Lead experience in Oncology trials (from pharma or CRO perspective).
  • Expert knowledge of base SAS, SAS macros, SAS/STAT, and in 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 a keen attention to detail.
  • Fluency in English – both verbal and written – is a must.
About Fortrea

Fortrea is a global CRO with a passion for scientific rigor and decades of clinical development experience. We provide 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.

We offer a rewarding and meaningful work environment, highly competitive compensation packages, and a genuine work-life balance. Our team is committed to delivering high-quality solutions and making a meaningful global impact.

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