REMOTE PRINCIPAL STATISTICIAN WITH ONCOLOGY GAITHERSBURG, MD
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 Client product team.
Leadership to statistical staff on the indications/projects so that all work is carried out with regards to Client 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.
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.
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, program design and data analysis and interpretation.
Experience of regulatory interactions and/or submissions.
Excellent communication skills and ability to build strong relationships.
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.
Oncology experience is required.
Job Dimension s:
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.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:
ALPHA'S REQUIREMENT #18-01296
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
provided by Dice (BIOTSTATISTICIAN over 5 year(s) ) AND (PRINCIPAL OR DIRECTOR OR MANAGER ) AND(ONCOLOGY OR TUMORS OR CANCER ) AND(RECIST )