12 month rolling project - minimum of 4 years
Job Summary:
Working for the major International company on their long term projects you will provide programming support and validation of analysis data sets, pooled datasets, statistical summary tables, figures and patient data listings for phase I - phase III clinical trials, ISS & ISE, primarily using SAS.
Accountabilities/Responsibilities:
*Provide output for the Clinical Study Report, the Integrated Summary of Safety (ISS), the Integrated Summary of Efficacy (ISE) and electronic submissions.
*You will work with biostatisticians and programmers based also in other sites globally.
*This position will require a significant training investment for the use of client specific processes / procedures in particular, SAS macros, creation of analysis data sets and dataset structures. Need for ensuring standardization of programs where applicable.
*Apply knowledge of clinical data, the design and phases of clinical trials, statistics, relevant regulations and the pharmaceutical industry to the implementation of tasks.
*Handle complex statistical programming issues independently and be familiar with study programming issues. Bring ideas for new projects and take the initiative to solve issues.
Essential Skills & Capabilities:
At least 3 years Statistical SAS programming experience with prior experience in pharmaceutical related field is required.
Working knowledge of clinical legislation (FDA, EMEA), Good Clinical Practice (GCP) and Clinical Data Interchange Standards Consortium (CDISC).
*SAS expert
*Fluent in English
*Ability to evaluate processes and situations in an orderly and rational manner asking questions and identifying missing information.
*Must be able to determine relationships between different parts of a problem and identify appropriate solutions.
*Accurately and efficiently work towards quality results
An excellent opportunity awaits for this renewable contract. Interview times booked and full job specification to review...
If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on.
For further details or a confidential conversation please contact me directly:
James Carrera
Manager - Statistics, Biostatistics & Programming
Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665
james.carrera@secpharma.com
http://uk.linkedin.com/in/jamescarrera
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician