Senior Director, Biostatistics

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, Amgen, Pfizer, and Gilead but wholly-owns or controls its three 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 Human Resources. 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 prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to [email protected] 

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.

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 $290,460 - $306,690

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