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CONTRACT: Senior Statistical Programmer
Mainland Europe
12 month rolling contract
START DATE: ASAP but they can wait until September for the right candidate
Telephone Interview slots booked and confirmed for the next two weeks.
Job Summary:
Responsible for all programming aspects (analysis datasets, pooled datasets, listings and tables) of individual Phase I-IV clinical trials and project level activities for small drug project / indications.
Accountabilities/Responsibilities:
1. Lead the programming activities for a trial, early phase project, indication, or publication activities; lead a complex/large project under supervision of a Program Statistician / Group Head.
2. Maintain efficient interfaces with internal and external customers with support of SR management and the Program Statistician.
3. Develop resource plans as required with support of the Group Head.
4. Develop and comply with project / study standards and specifications following internal guidelines.
5. Make certain that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
6. Program, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for phase I-IV clinical trials and for SCS and SCE with high quality and within milestones.
7. In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings.
8. Support quality control and quality audit of deliverables.
9. Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation.
10. Participate in the selection of CROs and supervise the SR trial activities of the CROs.
11. Provide input on process improvement initiatives and participate in non-clinical project activities.
Essential Skills & Capabilities:
Educated to degree level in mathematics, statistics or related subject
At least 3 years experience in a programming role supporting clinical trials / or in the pharmaceutical industry
Intermediate knowledge of / experience with SAS software.
Good understanding of global clinical trial practices, procedures, methodologies.
Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH).
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.
We also have a broad variety of other Biometric specific vacancies available in the UK and throughout Europe. Inclusive of SAS programming, Statistical, Clinical programming, Data Management functions, Regulatory Affairs, Clinical Research, QA, Compliance & Validation.
SEC Pharma are acting as an Agency and or Employment Business
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