Job Overview :
Principal Statistical Programmer required to work for Covance within Early Phase
Excellent opportunities to progress
Varied, fast paced environment
Office based in Leeds, Yorkshire, UK or work from home anywhere in Europe or South Africa
Candidates must have experience of working as a Lead Statistical Programmer within a Biotech, CRO or Pharma company within Europe or South Africa
Join our growing team and discover your extraordinary potential by working as a Covance Principal Statistical Programmer within our Early Phase statistical programming department.
As a Principal Statistical Programmer at Covance you will provides technical leadership with responsibility for delivering SAS programming services to clients and project teams, whilst maintaining optimal department processes and implementing effective project specific strategies.
The Principal Statistical Programmer will work with the senior team to provide guidance, mentoring and training to Statistical Programmers to ensure best working practices are maintained.
Working within early phase statistical programming we offer, in a word, variety
In the type of studies : PK, Bioequivalence, Metabolism, Dose Escalation etc. and Sponsors
In Early Phase we are not assigned for years to the same study, so you will be exposed to multiple studies for clients with different needs as well as working with talented internal colleagues
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 defence 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 a lead statistical programmer on complex studies in clinical research
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
Excellent organizational, time management and project management skills with team leadership experience
Self motivation and ability to work independently without appreciable direction
Ability to apply extensive technical expertise and the full knowledge of other related disciplines to provide consultancy and advice on programming and wider related issues to other departments and disciplines
Excellent problem solving skills, a proactive approach, anticipating issues and working to ensure they are avoided or resolved as quickly as possible
A willingness to make decisions seeking advice from statistical programming managers or directors to confirm decisions when necessary
Ability to promote a good team working environment, providing the client with a high quality service while recognizing our business needs
A proactive approach to developing and maintaining effective working relationships with staff in other disciplines, often in other locations and in working to achieve consistent processes and standards across them
NO AGENCIES PLEASE