Lead Statistical Programmer

hace 3 días


Barcelona, Barcelona, España Mai Fortrea Development A tiempo completo
Main Responsibilities:

As a Lead Statistical Programmer in our Flexible Solutions business unit, you will play a crucial role in the successful delivery of complex oncology projects for a renowned pharmaceutical company.

You will oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interaction with other departments.

Key responsibilities include:

  • Planning, executing, and overseeing all programming activities on a study
  • Overseeing SDTM, ADaM, and TLF development, performing Senior Review of outputs
  • Liaising with other Sponsor departments for additional programming needs, as required to support publications, medical writing, and additional development needs and analyses
  • Ensuring all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times
  • Mentoring less-experienced team members in best practices around SDTMs, ADaMs, and TFLs while ensuring adherence to department standards and processes
Your Profile:

We are seeking a highly skilled and experienced Lead Statistical Programmer with a strong background in statistical programming within clinical trials in a biotech, CRO, or pharmaceutical company.

Key qualifications include:

  • A degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  • 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 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
About Fortrea:

Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience.

We provide 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.



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