Scientist / Biostatistician, Quality Control Analytical Technologies

Location
Novato, California
Posted
Jun 09, 2022
Ref
oI8Aifws
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
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 will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

Role

The Biostatistician is responsible for providing leadership for the statistical design of analytical method establishment as well as statistical design and trend analysis of product and reference standard according to ICH.  The analytical method statistical design elements include trending method performance and release and stability specification setting, validation, optimization, development, troubleshooting, and transfer of molecular biological, biochemical and chemical evaluations for drug substance / drug product under cGMP guidelines and procedures.  The Biostatistician is expected to provide strong cGMP knowledge and expertise with regard to ICH, USP, JP and other guidance documents to team members.  The Biostatistician is responsible for supporting technical review and documentation for Quality Sciences and Technology (QSAT), site QC, Contract Test Labs, and other stakeholders for analytical methods and supporting the preparation of regulatory submission documents.  Strong teamwork/collaboration, written and verbal communication skills are essential. 

The candidate is expected to apply critical thinking to the statistical analysis, present results and conclusions, serve as a key subject matter expert for regulatory inspections as well as training and educational development of other staff members.

Key Responsibilities

  • Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
  • Provide statistical oversight on projects in the assigned programs/projects, ensuring sound statistical methodologies in analytical method study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis and reporting.
  • Provide statistical input in protocol design and development to ensure appropriate statistical power for analytical method transfers, validations, and Design of Experiments. Participate in the writing of method study protocols and ensure statistical soundness. Promote and participate in Quality by Design efforts and defining design space for analytical methods (and other areas, as required).
  • Work effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization.
  • Influence analytical method development and implementation plans, regulatory and commercial strategies for a wide range of drug development candidates, including ATMPs.
  • Analyze, trend, and review development and quality control non-routine, release, and stability testing data, including assessments of critical reagent qualification and performance.
  • Provide statistical design and analysis to establish product shelf-life as well as shelf-life extensions; setting or updating in-process and release and stability specifications.
  • Provide statistical design and analysis for monitoring reference standard stability and performance.
  • Oversee and or author experimental design and report writing—often for direct submission to pharmaceutical regulatory agencies.
  • Contribute to the development, optimization, transfer, validation and troubleshooting for analytical test methods.
  • Draft and revise QC SOPs for statistical procedures and align practices across the organization, contribute to data review, interpretation, and approval of results and reports.
  • May have one or more direct reports and is expected to provide technical and cGMP knowledge and guidance to the entire team.
  • Interact directly with regulatory agency inspectors during audits.
  • Interface with other BioMarin departments (QCAT, Site QC, Technical Development, Quality Assurance, Product Quality Leaders etc.) and contractors as necessary.
  • Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
  • Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives.
  • Other duties as assigned.

Required

  • A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 2 years’ relevant experience or an MS degree in these fields with at least 5 years’ relevant experience, with demonstrated ability and performance.
  • Experience successfully influencing effectively across functions and levels of an organization.

Highly Preferred

  • Expertise with JMP software
  • Experience and/or training with Quality by Design approaches for analytical methods
  • Experience with LIMS
  • Relevant experience in a matrix organization is desirable

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.