AX-7282 Head of Biostatistics and Data Management
Leading molecular imaging company require a Head Biostatistician to manage & co-ordinate statistical planning, programming, data management, analysis & reporting in support of new indications for R&D projects.
Key role supporting R&D projects, particularly of clinical studies and programs
Strong pipeline and new indication opportunities
Reports into the Chief Scientific Officer
Opportunity for talented individuals to work closely with highly experienced leaders with a track record of building successful businesses founded on quality science.
Opportunity for some home working
Acts as the primary contact for and oversees all data management and statistics activities performed by CROs/vendors, from study start-up through reporting;
Acts as the responsible for all statistical aspects including trial design, programming, analysis and regulatory filing strategy.
Collaborates on protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
Authors/reviews Statistical Analysis Plan (SAP) based on the protocol, including development of tables, listings, and figures shells
Authors/reviews sections of the clinical study report and publications as needed
Work with external vendors to create eCRFs and study databases, statistical analysis plans and statistical outputs.
Support the development of data transfer agreements and specifications with various vendors
Lead development of data reports and facilitate cross-functional data review for assigned studies or programs
Provides statistical input and support to Regulatory submissions globally and participates in regulatory meetings as needed
QUALIFICATIONS / EXPERIENCE REQUIRED:
Graduate degree in mathematical or scientific discipline ; post graduate degree (MSc/PhD) in statistical science
Substantial relevant drug/biologics development experience in biostatistics in a biotech, pharma or CRO company; experience in oncology and/or imaging is a plus.
Strong project management
Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials.
Demonstrated knowledge of all relevant statistical regulatory guidance (e.g, FDA, ICH and EMA) and submission data standard requirement (e.g. CDISC)
Strong understanding of clinical trial data and GCP requirements
Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing. Other clinical software (e.g. R) are desirable.
Experience in people management and CRO management is desirable
Experience in data management and EDC is desirable
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Rebecca Bray at AXESS Limited on 020 8560 2300 quoting reference 7282.
To apply, please click the APPLY ONLINE button.
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