Location: Cambridge or Home based
Closing Date: 07 Dec 16
Salary (£): On Application
• 12 month FTC initially (direct with client on salary and benefits) • Office based in Cambridge or homebased • Biotech company • Early Phase
My client were founded in 1998 and is listed on both the NASDAQ Global Market and AIM, a market of the London Stock Exchange. They are licensed by the UK Home Office to work with a range of controlled drugs for medical research purposes.
Their vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications. Their strategy is to build on their world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates.
Their lead product is currently in Phase 3 FDA clinical trials being studied in a number of catastrophic childhood-onset epilepsy syndromes. The product has been granted orphan drug status in those indications. They have assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical products. They maintain in-house control over all aspects of the cannabinoid product development process. They also hold GMP manufacturing licenses for the manufacture of pharmaceutical products for both clinical trials and commercial purposes.
• The Senior Statistician is a member of the clinical team and is responsible for statistical input, including SAS programming, to clinical studies.
• The Senior Statistician must ensure that activities and processes performed are conducted according to company requirements. This position works closely with other team members.
• Act as representative Statistician on study teams, so as to provide timely input.
• Statistical input from inception through to reporting of Phase I, II and III studies, ensuring high scientific standards for all studies.
• Perform statistical analyses of data and interpret results, ensuring validity of conclusions.
• Respond to regulatory questions regarding submissions.
• Interact with Data Management personnel as necessary to ensure that the data are in usable format; perform statistical diagnostics prior to database locking.
• Prepare and coordinate for blinded data review meetings prior to database lock.
• Perform ad hoc review of data and analyses following unblinding, as required.
• Ensure that appropriate programs are developed for reporting clinical studies (if applicable).
• Perform statistical quality control review and program validation for studies (if applicable).
• Interact with report writers in the production of clinical study reports and other documents containing statistical information. Review draft documents.
• Master’s degree in Statistics or a subject with a major statistical component with at least three years of relevant experience (production of statistical analysis plans and statistical reporting/generating TFLs are essential for this role).
• Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
• Proficient in the use of computers and especially the SAS system.
• Ability to perform and interpret statistical analyses of clinical data.
• Have a good understanding of clinical data, including data quality issues.
• Experience in early phase (Phase I/II) with excellent understanding of PK and the statistical reporting/analysis of early phase/PK studies (critical for the role as the main purpose would be to act as the study statistician for early phase studies).
• Excellent knowledge of SAS.
• Life Assurance
• Private Medical Insurance
• Health Cash Plan
• Income Protection
• Employee Assistance Programme
• Season Ticket Loans
• Child Care Vouchers
• Group Personal Pension Scheme
To apply please send a copy of your CV to firstname.lastname@example.org, 01753 216725.
Please note, if your skills/experience do not match the requirements for the role you may not get a response.
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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