COMPASS EXECUTIVES

COMPASS EXECUTIVES London, UK
Dec 09, 2018
Full time
Job Title: Director - Biostatistics | Pharma | Clinical Location: London Salary: £85,000 - £100,000 Compass Associates are honoured to be working in partnership with an outstanding pharmaceutical company that are renowned for their breakthroughs in rare disease and gene therapeutics. This opportunity will allow you the chance to work with a company that prides themselves on really making a difference to the world. With ever increasing growth in the market they are looking to expand, offering this unique position for an exceptional applicant. Role Description The Director Biostatistics is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Senior Director Biostatistics, this role provides a unique opportunity to contribute strategic statistical thinking to all aspects of clinical drug development in a dynamic environment. In this role you will be expected to provide leadership and guidance as the lead statistician on one or more project teams. As a principal member of the Program Team, you will be required to provide the statistical strategy for the project and will be accountable for all statistical aspects of clinical studies and submissions paying particular attention to data and statistical quality, relevance to regulatory requirements, and scientific validity. This is a hands-on role in which you will be expected to provide everything from high-level strategy to ad hoc analyses. Core Responsibilities Collaboration with clinical and regulatory colleagues to develop strategy for clinical development. Statistical input into protocol development including advice on study design and writing the statistical section of the protocol. Review of CRFs and all data management documents. Writing and/or reviewing Statistical Analysis Plans including design of table shells Oversight of preparation of statistical outputs including interpretation of results of statistical analyses Statistical input into CSRs and submission documents including preparation of statistical methods and results sections incorporating statistical conclusions Response to questions from regulatory authorities Statistical representative on Program Team Attendance at regulatory meetings as key statistical consultant Management of vendors (CROs and/or consultants) providing statistical services Mentoring and development of junior staff both within the biometrics function and cross functionally Requirements To be considered for this role you will be able to demonstrate extensive experience of working as a statistical leader in drug development. You will have built expertise in a range of statistical methodologies with practical applications and have the natural ability to communicate complex statistical concepts to non-statisticians. You will have excellent and demonstrable leadership, project management, and interpersonal skills, and have significant experience in managing and working with CROs and consultants. You will have a strong knowledge of CDISC standards, as well as have proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development. As a self-starter you will have the ability to work on cross-functional teams, and you will ideally have experience working in rare diseases or in trials in small populations. Experience with Bayesian methodology would be an advantage Education & Key Skills: MSc or PhD in statistics or related discipline Solid experience working as a statistician in drug development including significant interactions with regulatory authorities Proficiency with SAS required, experience with R an advantage Good knowledge of CDISC standards Excellent communication skills Proven leadership skills If you would like to be considered for this exciting opportunity please contact David Jolley directly on or . Alternatively email an updated CV via the button below. Recommendations Compass Associates Ltd is acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation.