Executive Director, Biostatistics, Real-World Evidence/ Health Economics and Outcomes ResearchLocation 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 Senior Director / Director / Associate Director of Biostatistics, Real-World Evidence (RWE) / Health Economics and Outcomes Research (HEOR), is responsible for
- Providing strategic and operational statistical leadership for real-world evidence (RWE) strategies, including observational research, and health economics and outcomes research (HEOR) projects across company portfolios.
- Functioning as a point person and subject-matter expert to collaboratively understand the real-world evidence needs, develop strategic plans, make recommendations on fit-for-purpose data and analytics solutions, apply rigor in observational study designs, statistical methods, and ensure appropriate interpretation of results.
- Collaborating and contributing to functional, cross-functional, enterprise-wide or external networks, working groups, or initiatives in order to investigate and critically appraise tools and technologies to better leverage and more effectively utilize real-world data and analytics to support the business.
- Understands the real-world evidence needs, asks the right scientific questions, and dives into complex health datasets (e.g., electronic health records, administrative claims, patient registries) or clinical trial data, to inform internal and external stakeholders on the incidence, prevalence, burden of illness, natural history of diseases, real-world outcomes of treatments, and to support evidence generation.
- Collaboratively develops strategic plans, makes recommendations on fit-for-purpose data and analytics solutions, applies rigor in study designs and analytical methods, produces high quality analyses, and ensures appropriate interpretation of results.
- Collaborates and contributes to functional, cross-functional, enterprise-wide or external networks, working groups, or initiatives in order to investigate and critically appraise tools and technologies to better leverage and more effectively utilize real-world data and analytics to support the business.
- Works with the Head of Biostatistics and other leaders within Biometrics to organize, plan, manage, and control deliverables (both internal and external) in support of company objectives and to communicate findings to internal and external stakeholders, regulatory, health technology assessment (HTA) bodies and scientific communities.
- Supervises biostatistics activities and allocates resources to effectively provide statistical leadership to RWE / observational research /HEOR programs and to successfully realize project deliverables against goals and timelines. Supervisory responsibilities include related activities of staffing, budgeting, planning, validation, and communication.
- Assures effective integration of Biometrics work with all other functions and cultivates the application of statistical principles across company portfolios.
- For Senior Director: a minimum of 10 years’ experience in pharmaceutical and/or biotech industry;
- at least 3 years’ experience managing other biostatisticians or real-world evidence analysts or CROs.
- at least 5 years of relevant work experience in RWE/observational research/HEOR.
- For Director / Associate Director: a minimum of 8 / 6 years’ experience in pharmaceutical and/or biotech industry.
- at least 3 / 2 years of relevant work experience in RWE/observational/HEOR research.
- Demonstrated experience effectively collaborating with cross-functional teams, managing project scope, and driving delivery in an evolving environment requiring proactivity, effective problem-solving, and prioritization.
- Demonstrated in-depth knowledge of RWE / observational research / HEOR work flow and processes; including but not limited to protocol development, statistical programming, data management, quality control, and study report preparation workflow.
- Demonstrated track record of developing and executing statistical analysis plans and/or overseeing external vendor work in support of RWE / Observational Research / HEOR work, including but not limited to disease understanding, burden of illness, natural history of disease, and post marketing requirements for regulators, payers and clinicians.
- Demonstrated excellent communication skills.
- Demonstrated skills to work independently to effectively deliver robust, timely, high-quality analytics in a constantly changing, diverse, and matrix environment.
- Demonstrated experience working hands-on with data, and proficient in manipulating large, complex datasets.
- Demonstrated knowledge of advanced theoretical and applied statistics.
- Demonstrated in-depth knowledge of statistical analysis methods on real world data in support of RWE / observational research / HEOR programs.
- Demonstrated solid programming skills (e.g., SAS or R).
- Demonstrated ability to lead, motivate, and mentor internal and external resources.
- Demonstrated ability to effectively review documents.
- Demonstrated knowledge of FDA, EMA and ICH regulations and guidelines, including good pharmacovigilance practices (GVP).
- Demonstrated knowledge of Guidelines for Good Pharmacoepidemiology Practice (GPP) and HTA requirements and guidelines.
- MSc or PhD in life science discipline (e.g., statistics, biostatistics, epidemiology, health economics, outcomes research, public health, or similar field).
- PhD degree 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.