Associate Director or Director, Biostatistics
Company: Cymabay Therapeutics
Location: Newark
Posted on: May 18, 2023
Job Description:
About CymaBay Therapeutics: CymaBay is a clinical-stage
biopharmaceutical company focused on improving the lives of people
with liver and other chronic diseases that have high unmet medical
need through a pipeline of innovative therapies.Position
Summary:This position will serve as a lead biostatistician for one
or more clinical studies. The position will provide statistical
support for study design, develop statistical analysis plan (SAP),
oversee execution of SAP, perform ad hoc analysis, collaborate with
study team to support clinical development, support ISS/ISE and
other NDA activities. This position will report to the VP of
Biometrics.Functions and Job Responsibilities:
Lead biostatistics activities in a
phase 3 or phase 4 study, with accountability of biostatistics
deliverables, including biostatistics support of clinical
development planning, clinical study designs, protocol development,
analysis planning/execution, clinical study report
table/figure/listings, statistical interpretations, and regulatory
submission activities.Provide biostatistics leadership and perform
study data reviews during clinical studies conduct to ensure that
clinical studies are in the right course as planned with proper
checking of data quality Collaborate with cross functional team to
facilitate and optimize the clinical development and registration
process to meet deliverables and timelines for statistical data
analysis and reportingManage biostatistics vendors, identify
potential risks and address issues Perform and/or validate
statistical analysis to support publication and conference
presentationAssist non-routine projects as applicable in support of
drug development activitiesParticipate in NDA preparation and
submission -Qualifications:
Master or PhD in statistics or
equivalent, with at least 8 years of relevant experience in
biotechnology or pharmaceutical industryExcellent interpersonal and
communication skills Extensive knowledge of GCP, ICH guidelines,
FDA regulationsGood knowledge and skills of programming in
SAS.Demonstrated ability in providing statistical input and
direction in clinical study designs, statistical approaches,
interpretation of findings and crafting of key messages. -The
anticipated salary range for Associate Director candidates who will
work in Newark, California is $185,000 - $200,000 and for Director
candidates is $215,000 - $235,000. - The final salary offered to a
successful candidate will be dependent on several factors that may
include but are not limited to the type and length of experience
within the job, type and length of experience within the industry,
education, etc. - CymaBay is a multi-state employer, and this
salary range may not reflect positions that work in other
states.Powered by JazzHR
Keywords: Cymabay Therapeutics, Newark , Associate Director or Director, Biostatistics, Executive , Newark, California
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