General Position Summary/Purpose:|
Responsible for designing, planning and conduct of clinical studies for a development molecule candidate. Adherence to PCYC standards, and all applicable regulations and guidelines. Contribute to technical and managerial leadership and organizational improvement. Responsible for providing leadership within the biostatistics department and making recommendations with regards to the strategic aspects of clinical studies as well as oversight of biostatistics project activities.
Key Accountabilities/Core Job Responsibilities:
Ensures that proper activities are undertaken for the timely and quality to meet PCYCs corporate objectives.
Collaborates interdepartmental and scientific activities, especially collaboration with medical monitors on protocol design (author or supervisor statistical methods section and generate study randomization)
Generate statistical analysis plan for assigned protocols (including Mock displays)
Assume responsibility for individual studies, write statistical portion of integrated clinical/ statistical reports
Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity
Supply statistical input for NDA submissions and in response to FDA queries
Provide support for investigator publications
Review case report forms to ensure that protocol objectives are met and project standards are maintained
Responsible for ensuring compliance with departmental and company goals
Effectively communicates timely and relevant updates to all team members involved
Expected to lead projects on all assigned clinical studies
Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials
Applies judgment and professional expertise independently
Able to prioritize and handle multiple tasks simultaneously
Ph.D. in Biostatistics or closely related discipline with a minimum of 10 years experience in pharmaceutical and biotech industry.
Education Requirements (degree, certifications, etc.):
PhD in Biostatistics preferred
Pharmacyclics, Inc. - 2 years ago