Andy Leake is recruiting for a Director & Biometrics Team Leader to join a company in the pharmaceutical industry at their site based in Cambridge, UK; Gothenburg, Sweden or Gaithersburg, USA on a permanent basis.
The main purpose of the role will be to:
- Lead, manage and develop a group of statisticians.
- Provide leadership to Biometrics and Information Sciences (B&I) staff on the product world-wide so that all work is carried out with regards to company standards and external regulations.
- Lead the strategic and operational planning of the B&I contributions to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of company products.
- Lead regular Biometrics Team meetings for optimal communication.
- Ensure Information Exploration Team is in place to deliver and document Ad-hoc work.
- Develop design options and provide high quality decision support.
- Quantify the Benefit, Risk, Value and Uncertainty of the emerging product profile.
- Set the standards (and enforcing compliance) for statistical work.
- Hold CRO/Partners accountable for the high quality standards of their deliverables.
- Represent the company and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications.
- Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
- Maintain understanding and awareness on new methodologies, therapy area and development initiatives.
- Provide leadership and direction to improvement projects/activities/initiatives and drive the implementation of best practice across the group.
- Develop contacts with international opinion leaders, consultants and collaborative groups.
- Ensure drug projects are successfully delivered in terms of scientific leadership and resourcing.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Leadership Capabilities.
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area.
- In depth knowledge of the technical and regulatory requirements related to the role.
- Extensive experience of development, program design, data analysis and interpretation.
- Experience of regulatory interactions and/or submissions.
- Managerial experience.
- Excellent communication skills and ability to build strong relationships.
- Excellent collaboration required - needs the energy to work across global & functional boundaries both internally and externally.
- Ability to apply statistical expertise to complex problems, problem solving and quality focus.
- Proven experience in the oncology therapy area is preferred.
This is an excellent opportunity to join a thriving global pharmaceutical company.
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 CL41821 in all correspondence.
You MUST be eligible to work in United States. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 16th April 2018
- Expires: 14th May 2018
- Reference: CL41821