Associate Director, Biostatistics (Study Lead)

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

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.

• Provide statistical leadership, as a member of cross-functional study team, during protocol development (study design, sample size justification, and safety/efficacy analysis methods) and throughout study duration  
• Collaborate with key stakeholders on study design and develop statistical analysis plan  
• Analyze and validate data to support study deliverables, including filings, reports, publications, and presentations. 
• Provide leadership and oversight for all Data Science deliverables for the study 

• Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes 
• Communicate Statistical Science and/or Data Science guidance as a representative or lead representative in cross-functional study teams (e.g., Study Execution Team) 

• Lead, and collaborate with others in Data Science, in the development of the statistical analysis plan (SAP) for the study including endpoint definition, sample size justification and statistical methodology; lead the execution of statistical analysis activities as outlined in the SAP and the related quality review and approval of deliverables 
• Collaborate with others in Data Science and cross-functional stakeholders on study design 
• Develop, and/or contribute to the development of, the following study-related deliverables: appropriate sections of study protocols, case report forms, data quality review and analyses, manuscripts, and sections of clinical study reports 
• Contribute to and negotiate study timeline with cross-functional team; identify Statistical Science study resource needs to meet timeline 
• Provide statistics area expertise to study team activities and deliverables 
• Serve as the statistical expert for the study throughout the study lifecycle and ensure accuracy and reliability of statistical results for the entire study 
• Work with cross-functional study team members (SET), other key stakeholders, and statisticians to analyze and interpret clinical study data 
• Identify and manage issues and risks and escalate, as appropriate 
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the