Job Overview :
Principal Statistical Programmer required to work for Covance as an experienced Lead Statistical Programmer on studies in Phases I-II
You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
Office based in in any of our European or South African offices or home based anywhere in Europe or South Africa
You must have previous experience as a Lead Statistical Programmer within a biotech, CRO or pharma company
Strong Oncology experience would be an advantage
Opportunities to develop and progress
Discover new opportunities to grow your career as a Covance FSP Principal Statistical Programmer. Our partner has an incredibly exciting and strong pipeline with over 45 ongoing oncology studies in Phases I and II.
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 within Europe or South Africa.
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.
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 complete SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
Produce Define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
Develop and / or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance and Client standards
Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
Mentor less-experience programmers in the processes around SDTMs, ADaMs and TFLs ensuring adherence to department practices and processes
Present and share knowledge at department meetings
Respond to QA and client audits and support qualification audits
Contribute to proposal activities and participate in bid defenses meetings in order to win new business
Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
Education / Qualifications :
BSc, preferably in computing, life science, mathematical or statistical subject
Experience as lead statistical programmer on complex studies in clinical research company
Knowledge in all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.
g. Biostatistics and Clinical Data Management.
Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
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