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Associate Director Biostatistics- Pharmaceuticals

  • Location Rockville, Maryland
  • Job-type Permanent
  • Reference BBBH96118


As Statistical Science Lead you will lead the statistical contribution and statistical design of drug project teams on projects transitioning into late phase development, products in Phase III development or in Established Brand teams in lifecycle development.
You will play a key role formulating the go/no decisions at the end of Phase II, in planning the product development, strategies, ensuring effective design and delivery of studies and submissions, interpretation and communication of results, in strong collaboration with external partners and support value demonstration and commercialisation of the product including Health Technology Assessment (HTA), and global publication team activities. Our Statistical Science Leads provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies.
Main Duties & Responsibilities:

  • 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 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 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.


Essential Requirements:

  • 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.