Please apply to the contact details below rather than to me
Many thanks
Chintu
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inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bio-analytical services, and strategic resourcing from a single clinical professional to an entire functional team.
Working in partnership with our client Boehringer Ingelheim, this unique role plays a key part in the continual support of one of our Functional Strategic Partnerships. As the successful candidate you will act as lead statistician on complex trials and across multiple global studies with project-level responsibility, you will also benefit from the strong strategic relationship enabling full visibility of the drug development cycle. As such we are able to offer all the advantages of working for a top-five CRO combined with the benefits of operating as an integrated member of a multi-functional client-specific clinical team.
You will be responsible for:
• Writing statistical methodology sections of individual protocols and formal Statistical Analysis Plans.
• Performing statistical analyses of data and interpreting results to ensure validity.
• Interacting with Data Management personnel as necessary to ensure that datasets are in usable format.
• Ensuring that appropriate analysis programs are developed for current clinical studies.
• Interacting with Medical Writers in the production of statistical and integrated clinical/statistical reports and other documents containing statistical information, including draft documents.
• Maintaining the highest standards of quality across all statistical work performed
• Interacting with other departments, such as Clinical Operations and Project Management, to ensure a high level of client satisfaction through the successful execution of projects.
• Acting as the lead Biostatistics contact with the sponsor to address statistical issues, and manage client expectations.
• Mentoring and supporting other members of the Biostatistics team and providing statistical expertise to other functions
• Contributing towards the development of client presentations and information sources.
And be able to meet the following requirements:
• M.Sc degree or Ph.D. in applied statistics with previous experience of working on clinical trials within pharmaceutical development
• Proficient in the use of SAS and demonstrated ability to perform statistical analyses of clinical data.
• Ability to work in a fast-paced, team-oriented environment.
• Strong attention to detail and quality control
• Proven organisational and planning skills and capability to work to challenging timelines
• Ability to read, analyse, and interpret common scientific and technical journals.
• Thorough knowledge of applicable regulatory rules and guidelines, e.g. ICH Guidelines.
In return you can expect:
• The flexibility to be office or part home/office based.
• A competitive remuneration package with excellent benefits including, free parking, healthcare, pension, annual performance bonus and more.
• A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organisation.
• The opportunity to work within a successful and rewarding environment.
We look forward to receiving your application.
Frances Wells
Senior Recruiter, EMEA
i3 International (UK) Limited
Star House, 20 Grenfell Road,
Maidenhead, Berkshire, SL6 1EH
T 01628 408444
F 01628 408428
M 44 (0) 7891182660
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http://www.inVentivHealthclinical.com
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