Director, IVD Biostatistics

Employer
Freenome
Location
South San Francisco, CA
Posted
Jan 12, 2022
Ref
5550916002
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Director,  In Vitro Diagnostics Biostatistics

As the Director, In Vitro Diagnostics Biostatistics at Freenome, you will be responsible for guiding statistical activities supporting Freenome’s product design and development efforts, especially those focused on analytical validation studies. You will provide insight into appropriate analytical validation study designs and statistical analysis techniques for in vitro diagnostics. You will also contribute to related scientific and clinical studies and associated publications and submissions.

How you’ll contribute

  • Partner cross-functionally with Assay Development, Clinical Laboratory, Regulatory and Quality Affairs, Scientific and Medical Affairs, and Clinical Development to develop and support execution of analytical verification and validation studies
  • Generate statistical materials supporting communications (written and in person) with regulatory agencies as part of regulatory submissions and design history file documentation
  • Provide guidance on how regulators may respond to novel aspects of Freenome’s analytical validation studies and help craft appropriate justifications
  • Author statistical analysis plans and statistical analysis sections of validation protocols and assist in interpreting data from development activities
  • Support product verification and validation activities, including leading analytical validation and quality control method development and validation
  • Provide statistical guidance and contributions to cross-functional R&D teams and clinical development teams, including design of experiments
  • Author and maintain Standard Operating Procedures (SOPs) for statistical methods and analysis within the quality management system
  • When relevant, develop novel statistical methods to support product design, verification and validation, manufacturing and quality testing 
  • Innovate and contribute creatively towards understanding novel multiomic assays and applications using statistical methods

What you’ll bring

  • Ph.D. or Master’s in statistics, biostatistics, or related scientific field with a minimum of six years of relevant experience
  • Hands-on experience with in vitro diagnostic development and regulatory submissions
  • Strong understanding of best practices, CLSI guidelines, ISO standards, and cGxP strategies supporting diagnostic product development and submissions to regulatory agencies
  • Solid understanding of quality requirements for biostatistics, analytical validation, programming, and data management
  • Excellent written and verbal communication as well as data visualization skills
  • Ability to manage multiple projects and priorities simultaneously
  • Strong programming skills in R, SAS, STATA, Python, or other programming language in support of regulatory submissions
  • Proficiency with MS Office and/or Google Suite 
  • Familiarity with Google Cloud Platform and BigQuery (or similar) is a plus

Freenome has adopted a COVID-19 vaccination policy to safeguard the health and well-being of our employees. As a condition of employment, our employees working on-site are required to be fully vaccinated for COVID-19, unless a reasonable accommodation is approved or as otherwise required by law.

About Our Science

We’re building technology to advance the understanding of cancer through multiple analytes derived from blood. These signals include cell-free DNA, methylation of cell-free DNA, cell-free RNA, circulating proteins and immune profiling from thousands of prospective samples. 

By developing novel statistical learning methods and applying them to integrate various -omics datasets, we’ve become a leader in modeling specific biological mechanisms. This means we’re capturing disease-dependent signatures, including gene expression, immune response, tumor burden, the tissue of origin and 3D chromatin structure. 

By building comprehensive discovery datasets and modeling critical biological systems, we’re learning the biological changes present in the blood during different stages of cancer. 

Our Culture

Freenomers are technical, creative, visionary, grounded, empathetic, and passionate. We build teams around divergent expertise, allowing us to solve problems and ascertain opportunities in unique ways. Freenomers are some of the most talented experts in their fields, joining together to advance healthcare, one breakthrough at a time. 

We value empathy, integrity, and trust in one another, and we respect the diverse perspectives of our colleagues and those we serve.  We assume positive intent and give each other the benefit of the doubt with the firm belief that we are a team working toward the same objectives.  We believe in empowering and supporting each other in a collaborative and dynamic environment. 

What does a successful person look like at Freenome?

Those who thrive at Freenome prioritize, manage, and execute their own goals with ownership and alignment with those of the company. They embrace our values of empathy, integrity, striving for greatness, servant leadership, trust, and holding themselves and their team accountable to these values. They crave collaboration with brilliant minds from disparate fields of study and believe that hiring and mentorship are fundamental to our success. Above all, they welcome and provide constructive feedback and criticism, trusting in others’ good intentions, and being secure in knowing that embracing mistakes is the best way to learn and grow. For those who pursue challenges, understudied problems, and want the opportunity to see their work impact the lives of millions of people affected by cancer every year, there’s no better place to be than Freenome.

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.