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, Encinitas , Director, Data Standard and Statistical Programming, Executive , San Diego, California
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