Remote Principal Statistician

Location: Gaithersburg, MD
Date Posted: 07-03-2018
Candidate Focus & Challenge –
•             To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an our product team.
•             Leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations
o             Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions
o             Quantifying the benefit, risk, value and uncertainty of the emerging product profile.
•             Holding CRO/Partners accountable for the high quality standards of their deliverables;
•             Represent us and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;
•             Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
•             Mentor/coach and support the education and training of Statistics staff in the technical arena.
Candidate Knowledge, Skills & Experience –
•             Leadership Capabilities @ Level 2
•             MSc/PhD in Statistics or Mathematics(containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
•             Knowledge of the technical and regulatory requirements related to the role
•             Experience of Development, programme design and data analysis and interpretation
•             Experience of regulatory interactions and/or submissions
•             Excellent communication skills and ability to build strong relationships
Job Dimensions –
•             Leadership role able to lead and direct elements of project work
•             Accountable for the statistical work within the project
•             Report to Senior Statistical Science Director
Other –
•             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.•
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