CK Clinical is currently recruiting for a Project Statistical Programmer for a defined development program for a project whose responsibility resides in Development, within a reputable pharmaceutical organisation in mainland Europe.
You'll oversee and manage project related activities for statistical programming activities for the defined development program, including assignment as an associate member of the clinical sub-team. As the primary Global Statistical Programming representative for assigned development program, you'll interact with, and serve as primary contact source for clinical team(s) and supporting departments (e.g. Regulatory Affairs, Biostatistics, and Data Management).
You'll function as lead statistical programmer or support programmer with respect to all statistical programming activities at the Senior Statistical Programmer level and serve as primary GSP contact to respond to questions by regulatory authorities.
You'll communicate and collaborate with the Program Biostatistician to ensure that Statistical Analysis Plans, and other analysis requirements, specifications, or derivation rules are consistent within and across individual studies.
If you are interested in applying, you should hold at least a Bachelor's degree (OR Equivalent) in a Scientific discipline and have proven Statistical Programming experience within the Biotechnology and/or Pharmaceutical industry, including clinical research organizations. You will have SAS Software Programming skills equivalent to a Senior Statistical Programmer to solve complex programming tasks according to SDTM and ADaM standard and will also have an advanced understanding of Clinical Trials Design and analysis, together with a basic understanding of integrated summaries of efficacy and safety required for regulatory submissions. As a Statistical Programmer, you will have a high level of analytical ability, exhibiting characteristics that are structured and methodical to ensure that sound, decisions are made. You should also be able to plan, perform, trouble-shoot and make decisions based on precedent, company policies, international and national regulations and Good Clinical Practice.
Please note this role is permanent, and salary is negotiable, dependant on experience.
For further information or a confidential discussion, please call me on +44(0)1438 870028 or email an updated CV for immediate consideration to [log in to unmask]
I hope to hear from you soon,
Priya Mukherjee BSc (Hons) MIRP CertRP
CK Clinical Limited
9 High Street
Stevenage Old Town
DD: +44 (0)1438 870028
Mobile: +44 (0) 7714 288632
Tel: +44 (0)1438 743047
Fax:+44 (0)1438 723800
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