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About the Role

IDEAYA is seeking a Senior Director of Safety Biostatistics to lead Biostatistics and Biometrics, providing statistical support for therapeutic development. This role collaborates with various departments, focusing on Drug Safety and Pharmacovigilance, and contributes to clinical development plans, protocols, SAPs, IB, DSUR, regulatory submissions, and publications. The position involves managing internal and external biostatistics teams to ensure high-quality deliverables and serving as the statistical representative for global drug approvals.

Responsibilities

Lead Biometrics members in cross-functional teams.
Provide strategic input to clinical teams and oversee development of clinical development plans and protocols in coordination with drug safety and pharmacovigilance, clinical sciences, clinical pharmacology, regulatory, and commercial functions.
Set statistical standards and methods to ensure quality delivery of clinical and pharmacology datasets.
Oversee, author, review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, associated publications, and other study and program level documents.
Manage and/or oversee biostatistical teams, including personnel and vendors, to produce statistical software and generate high-quality TFLs.
Act as a resource and mentor to development teams, translating scientific questions into statistical terms and statistical concepts into layman terms.
Challenge group assumptions and enforce rigorous statistical methodologies.
Assess, provide direction, and resolve complex stakeholder concerns.
Represent the IDEAYA biostatistics function internally and externally.
Stay current with applied statistical methodology and regulatory standards.

Requirements

Ph.D. or M.S. in Statistics or closely related field.
15+ years statistical experience in drug development.
At least 10 years in oncology drug development.
8 years extensive experience in supporting Drug Safety and Pharmacovigilance in pharmaceutical industry R&D.
Extensive hands-on experience writing complex protocols and SAPs.
Extensive hands-on experience performing interim and CSR analyses in oncology clinical development lifecycle from Phase 1 study to regulatory submission.
Direct involvement and responsibility in multiple NDA/BLA submissions with track records of approval of oncology drugs.
Expert knowledge of clinical trial design concepts and statistical methodologies.
In-depth understanding in safety analysis.
Demonstrated strong ability and leadership to work in a cross-functional team environment.
Good interpersonal, communication, writing and organizational skills.
Act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies.
Demonstrate good judgement and ethical behavior in all business activities.
Maintain patient and product safety as a top priority.
Report any suspected violations of law or Company policy through appropriate channels.

Skills

Biostatistics
Biometrics
Drug Safety
Pharmacovigilance
Clinical Development
Regulatory Affairs
Data Management
Program Management
Statistical Analysis Plans (SAPs)
Investigator's Brochures (IB)
Development Safety Update Reports (DSUR)
Clinical Study Reports (CSRs)
Statistical Software
Clinical Trial Design
Statistical Methodologies
Safety Analysis
Stakeholder Management
Communication
Writing
Organizational Skills

Location

South San Francisco, CA

Work Type

Onsite (four days per week)
Hybrid

Experience Level

Senior Director
15+ years statistical experience
10+ years in oncology drug development
8+ years experience in Drug Safety and Pharmacovigilance

Education Level

Ph.D. in Statistics or closely related field
M.S. in Statistics or closely related field

Salary/Compensations

$270,000 - $334,000

Benefits

Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
401k
ESPP
Wellness programs
Merit-based salary increases
Company discretionary short-term incentive plan participation
Company discretionary stock option awards

About the Company

IDEAYA is a precision medicine oncology company focused on discovering, developing, and commercializing transformative therapies for cancer.
Our approach combines expertise in small-molecule drug discovery, structural biology, and bioinformatics with internal capabilities for identifying and validating translational biomarkers.
We aim to develop tailored, potentially first-in-class targeted therapies for molecularly defined solid tumor indications.
Our pipeline includes product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs).
Our mission is to deliver the next wave of precision oncology therapies that are more selective, effective, and personalized to improve patient outcomes.
IDEAYA fosters an environment of brilliant minds, passion, commitment, high internal drive, inquisitiveness, data-driven innovation, collaboration, and teamwork.

Equal Opportunity

IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants based on any protected characteristic.
IDEAYA is an equal opportunity employer.
IDEAYA does not discriminate in hiring or employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status.
We are committed to providing reasonable accommodations to qualified individuals with disabilities.