Lead Statistical SAS Programmer, Oncology, Single Sponsor
il y a 2 semaines
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"}What you'll need:
- 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
- We are 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 a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas
- We have over 19,000 staff conducting operations in more than 90 countries, and are transforming drug and device development for partners and patients across the globe
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Paris, Île-de-France MAI Fortrea Development Limited Temps pleinTransforming Drug and Device DevelopmentAt Fortrea, we are a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. Our team provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across...
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