Director, Data Standard and Statistical Programming

Company: IDEAYA Biosciences
Location: San Diego
Posted on: November 14, 2024

Job Description:

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 .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, 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 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, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law).BenefitsAlong 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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Keywords: IDEAYA Biosciences, Orange , Director, Data Standard and Statistical Programming, Executive , San Diego, California