Senior Director, Safety Biostatistics

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IDEAYA’s Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to View email address on click.appcast.io. We ask that you only email your interest once.

Job Summary

About IDEAYA Biosciences: IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

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 team work to move science forward. For more information, please see

Location

South San Francisco, CA.

Position Summary

IDEAYA is seeking a Senior Director of Safety Biostatistics to join IDEAYA’s Biometrics team. The Senior Director of Safety Biostatistics will be a leader of Biostatistics and Biometrics at IDEAYA and will oversee and provide strong statistical support to the development of IDEAYA therapeutics in close collaboration with Clinical Development, Regulatory Affairs, Data Management, Program Management, and especially with focus with Drug Safety and Pharmacovigilance. Will be a key contributor to Clinical Development Plans, including the creation and execution of clinical protocols, statistical analysis plans (SAPs), and with focus in IB and DSUR 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 in general and especially in drug safety. This person will interact with external vendors, key opinion leaders and regulatory agencies in supporting safety aspect of statistical applications.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to

Senior Director, Biostatistics

Job Description

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 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, all in coordination with each specific function and data management.
• Oversee, author (as needed), review, and approve protocols, SAPs, CRFs, IBs, DSURs, CSRs, associated publications, and other study and program level documents.
• Manage and/or oversee the biostatistical teams on the responsible drug development programs at IDEAYA, including biostatistics personnel (line function members, programmers, consultants, and vendors) to produce and standardize 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 and 8 years extensive experience in supporting Drug Safety and Pharmacovigilance 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 safety analysis.
• Demonstrated strong ability and leadership to work in a cross-functional team environment with good interpersonal, communication, writing and organizational skills.

All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct.

Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

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).

• Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.

The expected salary range for the roleof Senior Director, Safety Biostatistics is $270,000 - $334,000. 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 in the office at the Company’s facilities for training & meetings, with 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.

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.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at View email address on click.appcast.io.