Senior Manager Statistical ScienceLocation 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.
BioMarin Data Science is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, Data Science builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The Data Science team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin.
Statistical Science Study Lead:
- As a Statistical Science Study Lead, the Senior Manager is responsible for leading and managing all Statistical Science-related activities for one or more studies or one program to ensure high-quality deliverables are executed in line with agreed timelines. This position supports or leads one of the BioMarin gene therapy programs. 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
For an assigned study, the Statistical Science Study Lead will perform a range of the following responsibilities depending upon the program complexity and program development stage:
- Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) and Data Analysis and Review Team (DART)) 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, Clinical Development Team, Medical Affairs Study Team)
Statistical Science Deliverable Development and Execution
- 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 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 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/MAST), other key stakeholders, and statistical scientists 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 program
- Understand and follow Statistical Science processes for study execution for all Statistical Science-related study deliverables
- Develop SOPs, WIs, guidelines, and templates
Clinical Development Focus
- Lead or support activities to prepare for meetings with regulatory agencies, including oral/written responses to agency questions, as needed
- Provide statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies and other regulatory submissions (such as IND safety update, PSUR)
- Ensure the quality of data and accuracy of analyses in regulatory interactions (e.g. submissions) or publications
The Senior Manager will be a subject matter expert and may lead or manage a team. This position will contribute to and make an impact on the department and the cross-functional process.
CAREER DEVELOPMENT – SKILL/COMPETENCY EXPECTATIONS
- Advanced knowledge of statistical methods for counts and longitudinal data
- Interprets complex and imprecise information, questions the assumptions of others, and makes appropriate inquiries to define problems accurately
- Understands, appreciates, and respects mutually beneficial relationships with peers and between BioMarin and its external vendors, KOLs, and other collaborators
- Leads by example and takes accountability for own team assignments and proactively offers support to/pitches in to help team members and team leaders, when appropriate
- Adapts communication style, message, and delivery method and medium to audience; knows when to ask for guidance on complex or difficult messages
- Demonstrates ability to analyze data independently, interpret clinical relevance of findings, and propose actions that impact clinical development plans, as appropriate
- Uses Base SAS and SAS procedures (or similar statistical software) to produce descriptive and statistical model results
- Understands the objectives/purpose of each drug development phase and the related key deliverables and regulatory/HTA requirements
- Demonstrates understanding of how trial(s) and drug(s) fit into BioMarin product strategy and associated regulatory/HTA considerations
- Develops explanations that reflect appropriate balance of statistical subject knowledge, scientific integrity, and results interpretation, to facilitate mutual understanding between BioMarin and Health Authorities/HTA agencies
- PhD degree preferred, or MS in statistics, biostatistics, data science or related discipline
- 3+ years clinical trial experience in pharmaceutical and/or biotech company with PhD; 6+ years with MS
- Must have worked on 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), electronic NDA and/or BLA submissions via eCTD, IND, CTA, or HTA interactions.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.