Who We Are
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancer.
Reporting to the CMO, the Head of Biometrics will build and oversee an organization with leadership and accountability for all biostatistics and statistical programming functions. He/she will play a key role in designing protocols, interacting with Health Authorities, as well as our partner contract research organizations (CRO).
He/she will also provide biometrics consultations to cross-functional teams as needed and will be responsible for recruiting, resourcing, and building infrastructure for Biometrics to support Bolt’s clinical research portfolio.
•Occasional travel required
• Ensure overall effective operations in biostatistics and clinical/statistical programming
• Oversee and lead direct reports and Biometrics input in clinical development plans, clinical translational protocols, regulatory documents, publications, internal and external meetings, and presentations
• Accountability for development, implementation and execution of statistical analysis plans that support clinical development plans and clinical protocols; assures statistical integrity, compliance, and accuracy
• Partnership with the Clinical Operations Team for the consistency and accuracy of statistical programming deliverables; including derived data definition, analysis file structure, analysis methodologies, and analysis results
• Continue to build and resource the Biometrics team; mentor and develop members of the Biometrics organization
• Establish best practices, identify the need, and drive the creation of functional standard operating procedures for biostatistics statistical programming
• Ph.D. in Biostatistics, Statistics, and/or Programming
• Broad and extensive knowledge of theoretical and applied statistics
• Demonstrated understanding of Phase I - Phase IV drug development
• Comprehensive understanding of regulatory guidelines for drug development
• Expert in the principles and techniques of data analysis, interpretation, and clinical relevance
• Expert level of proficiency with SAS and/or other statistical software packages
• Proven track record of fostering creativity, productivity, execution with a sense of urgency, teamwork, accountability, and cross-functional collaboration
• Entrepreneurial, self-starter with strong interpersonal and analytical skills; high ethical standards; and proven ability to work effectively with cross-functional partners and other internal stakeholders
• Excellent external networking, relationship and presentation skills, and a strong presence
• Must have operational leadership experience and management of direct reports
• Oncology experience strongly preferred
$250,000 - $325,000 a year
We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.
Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Bolt will consider requests for Reasonable Accommodations.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.