Director Biostatistics

  • Freeline
  • Job type: Permanent
  • Closing by 28/10/2019
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Description

Freeline is a privately-held clinical-stage biotechnology company based in the UK and Germany. We have an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment. Freeline has a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs.

Our gene therapy treatment builds upon the pioneering, world renowned work by the Freeline CSO, Professor Amit Nathwani. His award-winning scientific work has already been life changing for patients with Haemophilia B by making gene therapy safe, effective and reliable.

Innovation and entrepreneurial spirit are at our core, but our passion is working together as one team and tangibly making life changing impact. We are therefore looking for talented and passionate professionals who are driven and team orientated. If you share our vision for excellence and are looking for a high paced work environment, you may be a great fit for our team.

Role and responsibilities 

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)

Provide statistical input to clinical development plans and clinical trials

Works with clinical project managers and project physicians to plan clinical studies, and to analyse and interpret clinical study data

Participates 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

Contributes to development of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents

Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies

Provides oversight to CRO statisticians and programmers to ensure the quality of CRO deliverables and on QC of data outputs

Provide leadership to Biostats function at Freeline

Influences the proper use of statistics throughout Freeline's portfolio and contributes to the development of departmental standards and guidelines

Monitors project progress across the portfolio and ensures proper statistical resource allocation for successful project deliverables against goals and timelines

Contributes to outsourcing strategy at study and portfolio level for biometrics deliverables

Provide insights into innovative statistical application and operational strategies

Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions

Line management responsibilities for statistics and data management personnel. Mentor people working on the project

Promote teamwork, quality, and innovation

Create productive work environment. Ensure project team compliance with SOPs and departmental standards

Qualifications, education and experience 

Education:

M.S. in Statistics or Biostatistics required

Ph.D. in Statistics or Biostatistics preferred

Experience:

A minimum of 10 years clinical trial 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

Advanced knowledge of theoretical and applied statistics. Broad knowledge and superior understanding of advanced statistical concepts and techniques

Demonstrated leadership, project management, and interpersonal/communication skills

Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development

Experience in leading or participation in at least one electronic NDA and/or BLA submissions via eCTD

Excellent technical writing and verbal communication skills

Strong teamwork ability/commitment and individual initiative

Strong organisational skills with ability to effectively manage multiple studies

Job type

Permanent, full time

Location

Stevenage, UK

Apply now

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