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Assoc Director Biostatistics/ Principal Statistician : Remote

Artech Information Systems
New York, United States
December 28, 2018



Job Description:

Job Title: Assoc Director Biostatistics/ Principal Statistician

Job ID: AZNJP00007340

Location: Gaithersburg, MD (REMOTE)

Duration: 12 Months

Job Summary:

• Lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects

• Leadership to statistical staff on the indications/projects so that all work is carried out with regards to client 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 client 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 –

• Report to Senior Statistical Science Director