Statistical Monitoring and Analysis Lead (Associate Director, Quantitative Science)

Location:  Brisbane, California Category: Data Science

Description

Who We Are

From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.

  

Summary  
Quantitative Science aims to foster quantitative thinking coupled with data-driven strategies and decision-making to support various areas of BioMarin's business, including research, exploratory medicine, clinical trial monitoring, post-approval, and manufacturing.  
The Associate Director of Quantitative Science is a self-sufficient and high-impact position that focuses on supporting the statistical and data science needs in the risk-based monitoring (RBM) of clinical trials, serving in roles such as CSM lead (CSM: Centralized Statistical Monitoring), while also support other activities such as preclinical studies, biomarkers, application of AI/ML and development of analysis applications.  
This role requires exceptional communication and collaboration skills, a broad practical perspective on ensuring patient safety and data quality in clinical trials, and technical leadership in formulating, interpreting, and communicating statistical and data science approaches.  
The ideal candidate must demonstrate the following qualifications:  
  • Proficiency in statistics, advanced data science methods and application, and programming.
  • Experience in developing fit-for-purpose statistical methodologies and tools.
  • Excellent communication and collaboration.
  • Excellent matrix team leadership and interpersonal skills.
  • Subject matter expertise in applying statistics and problem solving in related areas, such as RBM, statistical monitoring, research experiments, and AI/ML.
  • Scientific curiosity
   
As the Centralized Statistical Monitoring (CSM) Lead, the Associate Director's primary responsibilities include:  
  • Leading a Data Science project team and collaborating with the study team.
  • Directing and supporting all data science activities that contribute to the statistical monitoring of clinical trials.
Performing all tasks required statistical thinking to programming.  
Detailed Responsibilities  
  • Leading the statistical monitoring of clinical trials for RBM studies.
  • Functioning as a statistical and analytical subject matter expert in statistical issues
  • Ensuring the development and operationalization of fit-for-purpose and effective statistical methodologies in the monitoring of clinical trials, including continuous development of analysis modules, libraries, and data visualization/reporting.
  • Ensuring the execution of RBM processes related to CSM and Quality Tolerance Limits (QTLs) throughout the study and working with the RBM business process owner to update processes as needed.
  • Taking responsibility for study specific RBM components at study start-up, such as CSM/QTL and assisting with key deliverables such as Risk Assessment and Categorization Tool (RACT), critical data, and Key Risk Indicators (KRIs).
  • Ensuring timely execution of CSM analysis and effective communication of discoveries to support Data Working Group (DWG)/Study Execution Team (SET) monitoring decisions.
  • Collaborating effectively with internal stakeholders from Clinical Development, Global Study Operation, Statistical Science, Data Management Science, as well as external stakeholders (e.g., RBM system vendor, CRO, etc.).
  • Collaborating with Data Management Science to provide statistical consultation for other data validation activities outside of CSM and QTL.
  • Proactively and efficiently working with study team to organize, plan, manage, and control deliverables against goals and timelines.
  • Keeping abreast of new RBM methodologies and regulatory guidance.
In addition to the above responsibilities, the Associate Director may also be involved in other quantitative mandates outside of risk-based monitoring, including but not limited to supporting research areas, exploring application of AI and Machine Learning, and developing analysis applications.  
  • Provide statistical support for experimental design, analysis, interpretation, and reporting of studies in research, biomarker development, manufacturing, and other areas.
  • Develop statistical algorithms and specifications for applications that enable researchers to analyze repetitive experiments.
  • Explore and develop the use of AI and ML for business impact and problem solving.
  
Education & Experience:  
M.S. in Biostatistics, Statistics, Data Science, or similar field required.  
Ph.D. in Biostatistics, Statistics, Data Science, or similar field preferred.  
Minimum Qualifications  
Years of experience in pharmaceutical and/or biotech industry:  A minimum of 5 (PhD) or 7 (Master’s) for associate director; A minimum of 2 (PhD) or 4 (Master’s) for senior manager.  
  
Preferred Qualifications:  
Overall:  
  • Proven ability to effectively collaborate with cross-functional teams.
  • Familiarity with clinical trial data and processes.
  • Knowledge of risk-based monitoring of clinical trials and statistical methodology; hands-on experience in statistical monitoring preferred.
  • Proficiency in developing and operationalizing fit-for-purpose analyses to assess study-specific risks in clinical trials.
  • Adaptability and ability to thrive in a constantly changing, diverse, and matrixed environment.
Statistics:  
  • Advanced expertise in theoretical and applied statistics or other relevant data sciences.
  • Extensive knowledge of statistical analysis methods, with a focus on statistical monitoring.
  • Strong programming skills in SAS, R, Python, and other statistical software packages.
  
Tool Development:  
  • Proficiency in developing specifications and designing analysis modules to operationalize CSM analysis, visualization, and reporting.
Supervisory:  
  • Demonstrated ability to lead, motivate, and mentor both internal and contract staff.
  • Effective review and evaluation skills for documents drafted by staff.
Regulatory:  
  • Thorough understanding of regulatory regulations and guidelines, particularly in the context of RBM.



Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.