OVERVIEW

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 aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally. 

BioMarin Statistical Science, as a function under 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. Data Science builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The Statistical Science team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin.

The statistical scientist is responsible for supporting the Statistical Science Study and/or Program Lead by taking the lead on assigned study team tasks, such as SAP development and CSR review, in a manner that meets expected quality standards and time frames.

RESPONSIBILITIES

The Statistical scientist will execute the activities below as assigned and under the guidance of the Statistical Science Program or Study Lead to support the overall completion of a study:

Cross-Functional Leadership

• May lead statistical activities for an assigned study working with clinical/medical lead and clinical operations.
• Close collaboration with statistical programming and data management.
• Understand regulatory requirements and assure quality/timely drug applications.

  Biostatistics Deliverable Development and Execution

• Participate in the development and execution of the statistical analysis plan (SAP) and the specifications for the statistical outputs (Tables/Figures/Listings).
• Contribute to the development, review, and/or quality control of protocols, randomization specifications, Clinical Study Reports (CSRs), eCRF, protocol deviations, Data Quality Review (DQR), clinical publications, and other key-study-related documentation.
  • Provide a sample size based on the specification provided by clinical scientists
  • Develop analysis specifications for programmers and review/verify analyses and programming codes for quality assurance
  • Conduct research (e.g., literature search, simulation studies) to support decision-making
  • Participate in development of standard reporting programs for clinical studies
  • Participate in development of standard CRFs for clinical data collection
• Provide statistical support throughout the lifecycle of the study assigned and ensure accuracy and reliability of statistical results for all activities.
• Work with representatives from study team and other statisticians to analyze and interpret clinical study data.
• Participate in activities supporting regulatory/HTA submissions.
• Participate in production of documents required to submit to Health Authorities.
• Work with vendors on specific study deliverables.
• Participate in production of DMC reports.
• Understand and abide by Data Science processes for study execution for all Statistical Science-related study deliverables.
• Review documents in development (ex. SOPs, work instructions, templates)
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

SCOPE

The statistical scientist will be required to work independently under the supervision of the Statistical Science program Lead. They will contribute to and make an impact on project or study team outputs.

WORKING ENVIRONMENT

Hybrid home/office requiring at least one day a week in the office with flexibility to come to office more often if needed.

SUPERVISOR RESPONSIBILITY

This role will not manage any direct reports.

EDUCATION

• PhD degree (preferred) or MSc in biostatistics.

EXPERIENCE

• 1+ years clinical trial experience in pharmaceutical and/or biotech company.
• An understanding of clinical drug development in industry required.

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions such as MS Word, Project, Excel and PowerPoint. 

Statistical software: SAS (required)/ R (optional)

Excellent programming skills.

HOW TO APPLY

Via our website: Sr. Manager, Statistical Science at BioMarin