Sr. Director of Clinical Data Sciences
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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 Director/Sr. Director of Clinical Data Sciences is a lead Data Scientist with training and significant experience in all biometrics disciplines, drug development, and clinical research. This person will provide Clinical Data Sciences and BioMetrics leadership and oversight for creating and implementing standards, evaluating new technologies and ensure on time and high-quality start-up of all phases of clinical trials and drug development programs. This individual is also responsible for production of Clinical Data Sciences deliverables, either personally or by supervising data scientist(s).
This position will actively participate in overseeing clinical data scientists , developing standard reporting programs, and standard CRFs in collaboration with cross-functional groups within the BioMetrics Department.
- Works with clinical scientists, statisticians, statistical programmers, clinical operations, and other functional area staffs to plan capturing, validating and analyzable data.
- Participates in new drug development programs as a Subject Matter Expert (SME) in data sciences area and provides data sciences leadership in the design data capture, technologies and define quality expectation of clinical development plans.
- Responsible for production of the following study-related deliverables, either personally or by supervising one or more data scientists.
- Works with the Head of the Clinical Data Sciences Department and 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 15 years clinical trial experience in pharmaceutical and/or Biotech Company (Sr Dir), Dir - a minimum of 12years clinical trial experience in pharmaceutical and/or Biotech Company, 10 years for AD.
- Advanced knowledge of clinical data sciences methodologies, including but not limited to EDC data capturing tools, eCOA, authoring data quality expectation document, knowledge of statistical procedures and 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, bio-stats, statistical programming and data validation workflow.
- in Statistics or other life sciences/data sciences required
- in Statistics or other life sciences/data sciences 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.