Director Of Biostatistics - North London
Stephanie Maccioni is currently working with an exciting start-up company who are looking for a passionate individual to establish their Biometrics function. They are a well backed biotechnology company developing gene therapies for haemotology disorders. They are currently looking for a Director of Biostatistics to join on a permanent basis.
Provides leadership and guidance as the lead statistician on one or more project team(s). Accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Acts as key statistical consultant within company. Has line management responsibility for statistics and data management personnel. Responsible for project staffing, resource planning and allocation within project team(s).
Key responsibilities will include:
Providing statistical input to clinical development plans and clinical trials Working with clinical project managers and project physicians to plan clinical studies, and to analyse and interpret clinical study data. Participating in new drug development programs as a Subject Matter Expert (SME) in statistics area and provides statistical leadership in the design of clinical development plans. Contributing to development of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents. Responsibility for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies. Providing oversight to CRO statisticians and programmers to ensure the quality of CRO deliverables and on QC of data outputs.Your Background:
M.S. in Statistics or Biostatistics required Ph.D. in Statistics or Biostatistics preferred A proven experience in pharmaceutical and/or Biotech Company Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS) Extensive hands-on experience with statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports) In-depth knowledge of clinical operations, data management, and clinical study report preparation workflow Experience of CRO oversight Experience with line management, hiring and personnel development. Experience working in rare disease study design and application of innovative statistical strategies
For more information or to apply for this position, please contact Stephanie Maaccioni on 01438 768713 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45387 in all correspondence.