- Senior Statistical Programmer required to work for Covance as a Lead Statistical Programmer on Respiratory studies in Phases I-IIIb
- You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
- Office based or home based in Italy
- You must have previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma company
- Opportunities to develop and progress
Discover new opportunities to grow your career as a Covance FSP Senior Statistical Programmer. Covance FSP are looking to hire an experienced Lead Statistical Programmer.
Our partner, an Italian pharmaceutical company, has an innovative Respiratory pipeline across Phases I to IV. The position offers a strong support network, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your Lead expertise whilst gaining exposure to a pharmaceutical working environment this is a fantastic opportunity.
This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere in Italy.
What is FSP?
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).
As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.
With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at: https://www.covance.com/services/functional-service-provision.html
Job Primary Functions
- Perform the role of the Lead Statistical Programmer
- 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 and the client, etc.
- Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
- Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and Reviewers Guides to support SDTMs and ADaMs
- Develop specifications for SDTMs and ADaM datasets
- Review SAPs and TFL shells from a programming perspective for studies
- Mentor less-experienced programmers in the processes around SDTMs, ADaMs and TFLs
- Present and share knowledge at department meetings
- Respond to QA and client audits, and support qualification audits
- Identify processes within programming that will increase productivity, quality and efficiency
- Ideally BSc in a computing, life science, mathematical or statistical subject
- Previous Lead experience as a Statistical Programmer within a biotech, CRO or pharma company
- Positive attitude and willingness to learn and contribute in a team setting and communicate effectively within the team environment
- Good organization skills and the ability to prioritize own work
- Self motivation and ability to work independently
- A cooperative and team-oriented approach
- Candidates must be fluent in English language (both verbal and written)
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
NO AGENCIES PLEASE
MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis on +44 (0) 1628 543 457. To apply, please click on the APPLY button.
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