Director, Data Standard and Statistical Programming

Ideaya Biosciences • San Diego, CA

436d • $225,281 - $238,300

About The Position

The position at IDEAYA Biosciences involves leading statistical programming activities in the development of targeted therapeutics for oncology. The role focuses on designing, developing, validating, and documenting SAS programs to generate analysis datasets and statistical outputs. The candidate will also supervise junior programmers and ensure compliance with industry standards and best practices in statistical programming.

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 of supervision responsibility.
• 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 integrated summaries ISE/ISS in multiple NDA filings with drug approval records.
• In-depth understanding of regulatory guidance and requirements in data standardization and statistical programming.
• Comprehensive knowledge of statistical programming environments and processes for clinical development from Phase 1 through regulatory submission.
• Strong expertise in CDISC including SDTM, ADaM, and CDASH.
• Advanced SAS programming skills with mastery of SAS/STAT procedures.
• 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.

Nice To Haves

• Knowledge of R programming and data visualization tools.

Responsibilities

• Plan and track statistical programming activities.
• Design, develop, validate, and document SAS programs for analysis datasets, data listings, summary tables, and statistical graphs.
• Develop or evaluate software tools and SAS macros to automate programming activities.
• Stay current with CDISC standards and improve statistical programming methodology.
• Create CDISC SDTM and ADaM files, SAS export files, and Reviewer's Guide for Electronic Submission.
• Supervise junior level statistical programmers.

Benefits

• Medical, dental, and vision coverage (100% company paid for employees and 90% for dependents).
• Retirement benefits.
• Employee Stock Purchase Plan (ESPP).
• Wellness programs.
• Annual performance bonus.
• Company equity refresh.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree