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Senior Statistical Programmer

hace 2 meses

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

We are seeking a highly skilled Senior Statistical Programmer to join our team at MAI Fortrea Development. As a Senior Statistical Programmer, you will play a critical role in the successful delivery of complex clinical trials for renowned pharmaceutical companies.

Key Responsibilities
  1. Review and advise on the development of complex statistical analysis plans (SAPs) and transfer files (TFLs)
  2. Develop and lead the development of complex specifications for standardized data transfer models (SDTMs) and analysis data models (ADaM datasets)
  3. Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs, and TFLs
  4. Produce and define XML/PDFs, analysis results metadata (ARM), case report forms (CRFs), and reviewer guides to support SDTMs and ADaMs
  5. Respond to quality assurance (QA) and client audits, and support qualification audits
  6. Identify and propose innovative ways to improve the efficiency, quality, and productivity of our clinical statistical programming business
  7. Maintain awareness of industry standards, global regulatory requirements, internal guidelines, and standard operating procedures (SOPs)
Requirements
  1. Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
  2. In lieu of the above: an equivalent completed vocational training and/or equivalent professional experience in statistical programming for clinical trials
  3. Solid professional experience as a statistical programmer within a biotech, CRO, or pharmaceutical company
  4. Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs
  5. Proven professional experience with SDTMs, ADaM datasets (safety and efficacy), and TFLs
  6. Solid knowledge of CDISC standards
  7. Prior experience working on oncology data (safety and efficacy) and/or on vaccine trials
  8. Submission experience is ideal
  9. Strong organizational skills, an autonomous and collaborative work style, a curious mind, and a keen attention to detail
  10. Business fluency in English, both spoken and written, is a must
About Us

MAI Fortrea Development 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 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 exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.