Lead Statistical SAS Programmer
responsibilities :
- 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/or 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, whilst 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. Join us at Fortrea. Stand at the forefront of Oncology research.
- You can be 100% home-based in EMEA or, if you prefer, you can work from our local office in your home country.
- 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
requirements-expected :
- 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 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)
- 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
- An autonomous, collaborative work style, a curious mind and a keen attention to detail
- Fluency in English – both verbal and written – is a must
offered :
- Rewarding and meaningful work in an established, diverse, highly profitable and respected global company
- Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.
- A genuine work life balance
- Flexibility in working hours
- A thorough onboarding with support from your personal mentor
- A permanent employment contract with Fortrea
- 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
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