Provide Statistical leadership to late-stage oncology clinical trials: developing trial design options and providing high quality decision support.
Statistical lead for a specific oncology molecule/indication in Health Authority interactions and maintain an accountability thread to TA head
Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting
Directs internal and external teams across multifunctional project or functional areas, leads initiatives to gather, organize, and analyze data from different sources such as virology, Case Report Forms, and patient tracking, works with management and Human Resources to satisfy short-term staffing needs, defends statistical aspects with regulatory agencies, develops staff capabilities, and recognizes/rewards desired performance
Is expected to oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources
Leads two or more components of departmental strategic initiatives

12 years + (Bachelors); 10+ years (Masters); 8+ years (PhD) of statistical analysis experience in the pharmaceutical or biotechnology industry (or at a CRO)
Industry experience in the statistical analysis of biomedical data using statistical software
Extensive hands-on experience in oncology drug development including design and analysis of phase 3 oncology trials and active participation in NDA/BLA filing through label negotiation
Demonstrated effective verbal and written communication skills and interpersonal skills are required
Examines functional issues from a broader organization perspective
Proven ability to determine the functions most critical to company success and to support priorities within functional area
Anticipates obstacles and difficulties of clients and acts to meet goals
Proven ability to pull together and lead highly effective teams and create a clear sense of direction
Proven ability to design and use all available vehicles for effective scientific communication within and outside the company.

discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
company-sponsored medical, dental, vision, and life insurance plans

Director, Biostatistics

Key skills