Full-Time

Lead Statistical SAS Programmer

Oncology

Posted on 10/25/2024

Fortrea

Fortrea

Biotechnology
Healthcare

Senior

Remote in UK

100% home-based in EMEA or local office in home country.

Category
Healthcare Administration & Support
Physicians & Surgeons
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • Ideally, 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 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) preferred
  • Ideally you will have 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
  • Fluency in English – both verbal and written – is a must
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

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A

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