Lead Statistical Programmer

hace 1 día

Madrid Centro, Madrid, España MAI Fortrea Development A tiempo completo
About the Role

We are seeking a highly skilled Lead Statistical Programmer to join our team at MAI Fortrea Development. As a key member of our team, you will be responsible for overseeing the successful delivery of complex oncology projects for a renowned pharmaceutical company.

Your primary focus will be on planning, executing, and overseeing all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interaction with other departments.

Main Responsibilities
  1. Programming Activities: 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.
  2. SDTM, ADaM, and TLF Development: Oversee SDTM, ADaM, and TLF development, perform Senior Review of outputs.
  3. Liaison with Sponsor Departments: Liaise with other Sponsor departments for additional programming needs, as required to support publications, medical writing, and additional development needs and analyses.
  4. Submission Activities: Support/oversee submission activities (especially in late phase team).
  5. Quality and Efficiency: Ensure all activities are conducted efficiently, with appropriate set-up of needed tools and macros, prioritizing quality at all times.
  6. Mentorship: Mentor less-experienced team members in best practices around SDTMs, ADaMs, and TFLs while ensuring adherence to department standards and processes.
Requirements
  1. Education: Ideally, a degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  2. Experience: In lieu of the above: professional experience in statistical programming within clinical trials in a biotech, CRO, or pharmaceutical company.
  3. Complex Oncology Experience: Solid experience with complex oncology clinical trials (minimum 5 years) and the corresponding datasets' content (safety and efficacy) and endpoints.
  4. Lead Experience: Lead experience in Oncology trials (from pharma or CRO perspective).
  5. Knowledge and Skills: 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.
  6. Autonomy and Collaboration: Autonomous, collaborative work style, a curious mind, and a keen attention to detail.
  7. Language: Fluency in English both verbal and written is a must.

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