Sr. Manager/Associate Director/Director, BiostatisticsLocation Brisbane, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Associate Director of Biostatistics is a lead Biostatistician with training and significant experience in statistics, drug development, and clinical research. This person will provide Biostatistics and BioMetrics leadership and oversight for all phases of clinical trials and drug development programs, including regulatory submissions. This individual is also responsible for production of Biostatistics deliverables, either personally or by supervising one or more statisticians.
This position will actively participate in overseeing the performance of Contract Research Organizations (CROs), developing standard reporting programs, and standard CRFs in collaboration with cross-functional groups within the BioMetrics Department.
- Works with clinical scientists, statistical programmers, clinical operations, and other statisticians to plan clinical studies, and to analyze and interpret clinical study data.
- Participates in new drug development programs as a Subject Matter Expert (SME) in statistics area and provides statistical leadership in the design of clinical development plans.
- Responsible for production of the following study-related deliverables, either personally or by supervising one or more statisticians: appropriate sections of study protocols, case report forms, statistical analysis plans, data analyses, manuscripts, and sections of clinical study reports and registration documents.
- Responsible for providing statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.
- Works with the Head of the BioMetrics Department and department peers to develop and monitor the department strategic direction and its alignment with company strategies.
- Keeps abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
- Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines.
- A minimum of 12 years clinical trial experience in pharmaceutical and/or Biotech Company (Sr Dir), Dir - a minimum of 10 years clinical trial experience in pharmaceutical and/or Biotech Company, 8 years for AD.
- Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS).
- Extensive hands-on experience with statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports).
- In-depth knowledge of clinical operations, data management, and clinical study report preparation workflow.
- Advanced knowledge of theoretical and applied statistics.
- In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data.
- Exhibition of comprehensive exemplary experimental techniques, following procedures with the utmost rigor and attention.
- Experience in leading or participation in at least one electronic NDA and/or BLA submissions via eCTD.
- Familiar with IND or CTA.
- MS. in Statistics or Biostatistics required
- PhD. in Statistics or Biostatistics preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.