CONTRACT: Clinical Statistician - Phase II/IV UK Based Contract
12 month rolling contract
Job Summary:
Provide statistical input to new protocols: draft the statistical
sections. Review the sections on study design and description of
clinical endpoints. You will be working on Phase II-IV Clinical Trials
Accountabilities/Responsibilities:
* For allocated studies, write the draft statistical analysis plan
which should include all relevant information required by the reporting
statisticians and be ICH-compliant. Arrange the project team review of
the plan, collate comments and run the team review meeting.
* For ongoing studies, advise on data collection: this includes
review of the proposed CRF (Care Review Forms) and CRF completion
guidelines.
* Collaborate with data management to ensure a quality database:
by reviewing the proposed edit checks, identifying any areas where
additional data checks may need to be built into reporting software,
advising on ongoing questions from the sites regarding CRF completion.
* Assess patient evaluability for study analyses: working with
statistical programmers to define software required to assess which
subjects will be included in the statistical analyses.
* Prepare the data analysis for the clinical study report: review
protocol deviations/violations, confirm the validity of the original
statistical analysis plan, program and conduct the original exploratory
efficacy analysis, review the formal safety and efficacy tables produced
by reporting statisticians.
* Write the biometric text: this should include all relevant
information to be included in the clinical study report together with a
detailed description of the statistical methods and a statistical
interpretation of the results.
* Liaise with writing group during production and review of the
clinical study report.
* Provide general statistical consultancy support: discussing
study issues with clinicians and external experts.
* Maintain statistical documentation
Essential Skills & Capabilities:
Educated to MSc level in Statistics / Biostatistics or related subject.
X years of statistical experience with x years of which gained with a
Pharma environment The ability to create statistical analysis plans SAS
knowledge Phase II onwards experience desirable, but not essential.
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.
For a confidential consultation call;
James Carrera
European Contracts Manager
Pharmaceutical, Healthcare & CRO division
1st Pharma People
"A Division of 1st IT People"
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
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