Job in Portugal, Lisbon ( Principal Statistical Programmer )

About Covance:
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you will have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential. For more information on Covance please visit: www.covance.com.

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

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:

·         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

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.

 

https://careers.covance.com/global/en/job/COVAGLOBAL44779EXTERNAL/Principal-Statistical-Programmer-FSP?utm_source=glassdoor&utm_campaign=na&utm_medium=jobpaid&iis=Jobboard&iisn=glassdoor