Lead Statistical Programmer, Oncology, Sponsor-Dedicated Solutions

3 weeks ago

Oslo, Oslo County, Norway MAI Fortrea Development Limited Full time

As a leading global contract research organization (CRO), MAI Fortrea Development Limited 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, our company is transforming drug and device development for partners and patients across the globe.

As a Lead Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex oncology projects for a renowned, innovative, and global top pharmaceutical company. Our sponsor is looking for Lead Statistical Programmers capable of overseeing studies from the Pharma side.

You will be involved in liaising with the entire study team as needed, including Clinical, Medical Writing, Safety, and Biometrics. This may be for either in-house programmed or out-sourced studies in either their Early or Late Phase team. It is a great opportunity to see more how this works from a Big Pharma perspective, while still being part of a global CRO with opportunity for future career growth.

The decision you make today could change the future of our patients tomorrow. You will work in an established, diverse, highly profitable, and respected global company.

You can be 100% home-based in EMEA or, if you prefer, you can work from our local office in your home country.

What else can you expect from us?

  • Rewarding and meaningful work
  • Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances
  • A genuine work-life balance
  • Flexibility in working hours
  • A thorough onboarding with support from your personal mentor
  • A permanent employment contract with MAI Fortrea Development Limited
  • 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 more than 20,000 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:

  • A 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)
  • Ideal knowledge in all aspects of clinical trials, from initial study set-up to study completion, with an understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management
  • 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

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