Director, Data Standard and Statistical Programming

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. 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 are applying these capabilities across multiple classes of precision medicine, including 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 an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.

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 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]

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

Local candidate applications only please. Relocation assistance will not be provided for this role.

What you'll do:

• Responsible for planning and tracking the statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting statistical analyses.
• Develop or evaluate software tools, SAS macros, utilities to automate programming activities and improve programming efficiency and quality.
• Stay current with CDISC standards, industry trend, best practices and improve statistical programming methodology. Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission when necessary.
• Supervise junior level statistical programmers

Requirements:

• BS/BA in Statistics or equivalent with 18+ years relevant work experience in bio-pharma statistical programming.
• At least 8 years of experience in statistical programming leadership roles with a minimum of 5 years with supervision responsibility on statistical programming teams.
• At least 8 years of direct experience in oncology drug development. Lead programmer with hands-on work in multiple complex registration studies from study initiation through CSR reporting.
• Experience with direct responsibility in integrated summaries ISE/ISS in multiple NDA filings with drug approval records.
• In-depth understanding of regulatory guidance and requirements in data standardization, statistical programming, and submission, as well as general knowledge of industry best practices and standards in data analysis and reporting.
• Comprehensive knowledge and deep understanding of statistical programming environments, processes, procedures, and roles for clinical development from Phase 1 through regulatory submission.
• Strong expertise in CDISC including SDTM, ADaM and CDASH.
• Advanced SAS programming skills in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a demonstrated mastery of SAS/STAT procedures.
• Able and willing in taking on hands-on work and producing high quality analysis outputs to support demands arising from company needs.
• Knowledge of R programming and data visualization tools is a plus.
• Experience in developing and implementing SOPs in DSSP and related areas.
• Excellent written and oral communication and presentation skills.
• Proven sound leadership for Biometrics teams.

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/San Diego, California office is $225,281 - $238,300. 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 opportunity 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.

Benefits

Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.

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.

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