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Director, Data Standard and Statistical Programming
IDEAYA BiosciencesSouth San Francisco, United Statesfull_timeVerifiedPosted 26 Sept 2024
💰 $238,300/yr($225,281/yr – $238,300/yr)
About the role
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 HR@ideayabio.com
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.
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 HR@ideayabio.com
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 qualit
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