Statistical Lead, Oncology, Clinical Trials

7 days ago


Oslo, Oslo County, Norway MAI Fortrea Development Limited Full time
About the Role

We are seeking a highly skilled Lead Statistical Programmer to join our team at MAI Fortrea Development Limited. As a key member of our team, you will be responsible for overseeing the programming activities on complex oncology projects, ensuring timely and high-quality delivery.

Key Responsibilities
  • Plan, execute, and oversee all programming activities on a study, including resource estimation, budget management, and timeline adherence.
  • Oversee the development of SDTM, ADaM, and TLF, performing senior review of outputs.
  • Liaise with other departments for additional programming needs, supporting publications, medical writing, and development needs.
  • Support and oversee submission activities, prioritizing quality and efficiency.
  • Mentor less-experienced team members in best practices around SDTMs, ADaMs, and TFLs.
Requirements
  • A degree in a relevant field, such as mathematics, life sciences, statistics, or computer sciences.
  • Professional experience in statistical programming within clinical trials in a biotech, CRO, or pharmaceutical company.
  • Solid experience with complex oncology clinical trials and corresponding datasets' content.
  • Lead experience in Oncology trials from a pharma or CRO perspective.
  • Expert knowledge of base SAS, SAS macros, SAS/STAT, and debugging SAS programs.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM.
  • An autonomous, collaborative work style, a curious mind, and a keen attention to detail.
  • Fluency in English, both verbal and written.
About Us

MAI Fortrea Development Limited is a 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 with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

We are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our team and be part of a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.



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