Dear Allstat,
Role: Statistician
Basic Purpose and objective:
To act as the lead statistician on selected single projects. To support the
lead statistician on projects, by providing statistical input into clinical
trials from design, through analysis and reporting. To support the lead
statistician on projects, by providing statistical input into clinical
trials from design, through analysis and reporting. To provide statistical
programming support for data summaries and listings, and validation
programming support in the production of statistical appendices. To
represent the Biostatistics department within the company and with
interactions with client companies and regulatory agencies, as required.
Supervisory responsibilities: Mentoring of Associate
Statistician/Statistical Programmer (as required)
Duties and Responsibilities (according to relevant guidelines, laws and
SOP's)
* Be familiar with and follow the departmental and company standard
operating procedures (SOPs) and working practices (WPs).
* Serve as a lead statistician on selected single projects.
* Ensure projects are well documented consistent with company SOPs and
working practices.
* Time management of own and team\'s time spent on projects.
* Interact with the sponsor on statistical aspects of the project.
* Produce sample size calculations. Provide input into study design and
statistical considerations, during protocol development. Review protocols
for completeness, appropriateness of clinical design and sound statistical
analysis. Contribute to writing appropriate protocol sections.
* Provide randomization schemes and appropriate documentation, on selected
projects.
* Develop statistical analysis plans, including table, listing and graph
specifications.
* Specify the general structure of the analysis database, provide
programming support for its development and validation.
* Produce statistical analyses and statistical appendices, with appropriate
documentation.
* Validate statistical analyses and statistical appendices, with appropriate
documentation.
* Prepare Statistical Reports, Integrated Summaries of Safety, Integrated
Summaries of Efficacy and other documents, as required. Contribute
statistical methods section for Integrated Clinical Statistical Reports.
Qualifications: BSc degree in statistics or related field. Advanced degree
(MSc) is desirable.
Skills and knowledge:
Strong knowledge of statistical principles underlying clinical trials, and
strong statistical skills.
SAS(r) programming skills, familiarity of other statistical packages
Familiarity with ICH Statistical and reporting guidelines and GCP.
Experience:
A minimum of 1.5 years experience in statistics within a Healthcare,
Pharmaceutical or a clinical research environment.
If you would like 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 a confidential consultation call Mathew Hogan on 0044 (0) 207 255 6665
or email your CV to [log in to unmask]
Mathew Hogan
Senior Consultant
Pharmaceutical, Biometrics & CRO Division
1st Pharma People
A Division of 1st-IT People
Tel: +44 (0) 207 255 6665
Fax: +44 (0) 207 255 6656
mailto:[log in to unmask]
<mailto:[log in to unmask]>
www.1st-pharmapeople.com <http://www.1st-pharmapeople.com/>
PLEASE NOTE: As of 31st May 2005 our office address will change to; 1st IT
People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T
3NJ. As a result of this, we do have a new telephone number of 0207 255
6665. Please note our previous phone number will still work.
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