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Statistical Science Director - Gaithersberg, USA

United States   •  Permanent, Full time

Andy Leake is recruiting for a Statistical Science Director 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 the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation of products.
-Leadership to statistical staff on the product world-wide so that all work is carried out with regards to company standards and external regulations
-Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions
-Quantifying the benefit, risk, value and uncertainty of the emerging product profile.
-Setting the standards (and enforcing compliance) for statistical work within the product.
-Holding CRO/Partners accountable for the high quality standards of their deliverables.
-Represents the company and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications.
-Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
-Develop relationships with international opinion leaders, consultants and collaborative groups.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
-Proven and in depth experience in pharma/healthcare or other relevant area.
-In depth knowledge of general and therapeutic area statistical methodology and regulatory requirements related to the role (Cardiovascular, Renal Medicine and Metabolic disease TA knowledge is preferred).
-Extensive experience of Development, programme design and data analysis and interpretation.
-Substantial experience of regulatory interactions and/or submissions.
-Strong Leadership experience.

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 CL41831 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: CL41831


  • Recruiter: Andy Leake
  • Phone: 01438 743047