Senior Director, Biostatistics
Location: South San Francisco
Posted on: June 23, 2025
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Job Description:
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage
precision medicine oncology company committed to the discovery,
development, and commercialization of targeted therapeutics for
patient populations with high unmet clinical needs. Our approach
integrates extensive capabilities in identifying and validating
translational biomarkers with small molecule drug discovery to
select patient populations most likely to benefit from the
therapies we are developing. We have developed an industry leading
platform and pipeline in precision medicine by applying these
capabilities across multiple approaches such as direct targeting of
oncogenic pathways and synthetic lethality, which represents an
emerging class of precision medicine targets. We believe this
diversified approach will enable us to deliver the right medicine
to the right patient to drive a more robust clinical response.
IDEAYA has established strategic collaborations with GSK, Merck,
Pfizer, and Gilead but wholly-owns or controls its four
most-advanced clinical programs and we are committed to building a
best-in-industry organization to deliver our precision medicines to
the people who need them. When you're at IDEAYA, you will be in the
midst of brilliant minds working on precision medicine therapies to
help cancer patients. We are passionate and committed about being
on the forefront of oncology medicine, which means we all have a
high internal drive that is at the very core of every person at
IDEAYA. We are inquisitive, ask deep questions, and are data-driven
innovators who like to collaborate and use teamwork to move science
forward. For more information, please see www.ideayabio.com .
Notice to Agencies and Recruiters: All open positions and candidate
activity are strictly managed through IDEAYA Biosciences, Inc’s
Human Resources department. Please note that our policy is that
recruiters do not contact employees/hiring managers directly to
solicit business and/or present candidates. Submission of
unsolicited resumes by agencies, with or without an agreement in
place with IDEAYA Biosciences, Inc., will not create any implied
obligation. Please note that failure to comply with this policy
will be a factor in developing or continuing a professional
relationship with IDEAYA Biosciences, Inc. Position Summary: The
Senior Director, Biostatistics will be a leader of Biostatistics
and Biometrics at IDEAYA and will oversee and provide statistical
support to the development of IDEAYA therapeutics in close
collaboration with Clinical Development, Regulatory Affairs, Drug
Safety, Clinical Pharmacology, Data Management, Translational
Development and Program Management team members. Will be a key
contributor to Clinical Development Plans, including the creation
and execution of clinical protocols and statistical analysis plans
(SAPs) as well as regulatory submissions and publications. Will
oversee, manage, and guide the IDEAYA biostatistics team (both
internally and externally) to ensure high quality and timely
deliverables. Will serve as the statistical representative in the
defense of the company position and approach on statistical issues
and drug approvals globally. This role has significant stakeholder
management responsibility with business partners. The
biostatistician leader has responsibility for driving optimal study
designs, data collection, analytic approaches, and rigorous
interpretation of data. This person will interact with external
vendors, key opinion leaders and regulatory agencies. This position
is based in our South San Francisco headquarter offices and
required to be onsite four days per week per our company policy.
What you'll do: Lead the Biometrics members in cross-functional
teams at IDEAYA. As a key member, provide strategic input to IDEAYA
clinical teams, oversee development of clinical development plans
and protocols in coordination with clinical operations, clinical
sciences, clinical pharmacology, regulatory, and commercial
functions. Set statistical standards and methods to ensure quality
delivery of clinical, translational medicine, and pharmacology
datasets, all in coordination with each specific function and data
management. Oversee, author (as needed), review, and approve
protocols, SAPs, CRFs, CSRs, associated publications, and other
study level documents. Manage and/or oversee the biostatistical
teams on the responsible drug development programs at IDEAYA,
including all biostatistics personnel (line function members,
programmers, consultants, and vendors) to produce statistical
software and generate high quality TFLs. Act as a resource and
mentor to the development teams of the responsible clinical
programs. Translate scientific questions into statistical terms and
statistical concepts into layman terms to support the team needs.
Challenge group assumptions and enforce rigorous statistical
methodologies. Assess, provide direction, and resolve complex
stakeholder concerns and 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. Have 15 years
statistical experience in drug development, including at least 10
years in oncology drug development in pharmaceutical industry
R&D. Extensive hands-on experience from writing complex
protocols and SAPs to performing interim and CSR analyses in
oncology clinical development lifecycle from Phase 1 study to
regulatory submission. Direct involvement and responsibility and
hands-on experience in multiple NDA/BLA submissions with track
records of approval of oncology drugs. Expert knowledge of clinical
trial design concepts and statistical methodologies with in-depth
understanding in time-to-event analysis methodologies. Demonstrated
strong ability and leadership to work in a cross-functional team
environment with good interpersonal, communication, writing and
organizational skills. $260,687 - $322,025 a year At IDEAYA
Biosciences, we care about our employees and strive to provide a
market-competitive total rewards package, including base pay, an
annual performance bonus, company equity, and generous health and
well-being benefits. The expected salary range for this role that
is based in our South San Francisco, California office is $260,687
- $322,025 The final salary offered to a successful candidate will
depend on several factors that may include but are not limited to
the office location where this open position is located, the final
candidates’ experience within their profession, experience in the
disease areas we are striving to make an impact in as a company,
length of time within the industry, educational background, and
performance during the interview process. The Company complies with
all laws respecting equal employment opportunities and does not
discriminate against applicants with regard to any protected
characteristic as defined by federal, state, and local law. This
position requires you to work onsite at the Company’s facilities,
with partial work-from-home flexibility, and the Company requires
that all employees working in its facilities be fully vaccinated
(except as required by applicable law). Therefore, this position
requires you to be fully vaccinated from COVID-19, subject to
reasonable accommodations for medical or religious reasons, and/or
as otherwise required by applicable law. The Company considers you
fully vaccinated once 14 days have passed since you received either
the second dose in a two-dose COVID-19 vaccine series or a
single-dose COVID-19 vaccine. The vaccine must have been FDA
approved, have emergency use authorization from the FDA, or, for
persons fully vaccinated outside of the U.S., be listed for
emergency use by the World Health Organization. Total Rewards:
Along with our inspiring mission, and highly collaborative and
inclusive environment, IDEAYA offers a competitive total rewards
package that reflects our pay-for-performance philosophy where
employees are eligible to be considered for merit-based salary
increases, company discretionary short-term incentive plan
participation, and company discretionary stock option awards (based
on board approval). Our comprehensive benefits package includes,
but is not limited to, medical/dental/vision coverage (100% company
paid for employees and 90% company paid for dependents), 401k,
ESPP, and wellness programs. IDEAYA is an equal opportunity
employer. In accordance with applicable law, IDEAYA does not
discriminate in hiring or otherwise in employment based on race,
color, religion, sex, national origin, age, marital or veteran
status, disability, sexual orientation, or any other legally
protected status. EOE/AA/Vets. California Job Applicant Privacy
Notice
Keywords: , North Highlands , Senior Director, Biostatistics, Science, Research & Development , South San Francisco, California