VP, Biostatistics

Location
Redwood City, CA
Posted
Jun 02, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

VP, Biostatistics

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.

Allakos is committed to developing innovative therapies that transform patients’ lives.  We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

Position Summary:
  • As a member of the Allakos team you will lead the Statistics team and have oversight for development plans, regulatory interactions, and HTA/commercial evaluation across multiple molecules and indications.
  • The ideal candidate needs to have a proven track record of functional leadership, mastery of statistics in drug development, as well as excellence in people management and development.
  • Your Role:
  • Statistical leadership to late-stage clinical trials: developing trial design options and providing high quality decision support
  • Work collaboratively with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
  • Uses knowledge of Regulatory requirements regarding statistical principles to ensure the company meets its Regulatory, scientific, and business objectives
  • Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
  • Negotiates project timelines given constraints, works with senior management and Human Resources to identify long-term staffing plans
  • Provides career development opportunities to staff, and participates in strategic risk assessment based on statistical analyses or principles
Qualifications and Expertise:
  • At least 15 years of industry experience with experience in GI therapeutic area preferred
  • Experience with global regulatory agency direct interactions including various types of face to face meetings and advisory committee experience would be an asset
  • Demonstrated history of successfully responding to various statistical information requests from regulatory authorities
  • Demonstrated ability to be an agile thinker with creative solutions to complex statistical, regulatory, and clinical trial issues
  • Significant experience with various aspects of drug development and the statistical support requirements including CMC and pre-clinical development
  • Demonstrated ability to effectively collaborate and communicate across functions to identify efficient and timely solutions
  • Experience with clinical operations functions and clinical study conduct as well as good knowledge of GCP and data handling standards
  • Willingness to travel (up to 25% of time)
The salary is competitive and commensurate with experience and qualifications.

The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership

Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.