Senior Biostatistician jobs in United States
cer-icon
Apply on Employer Site
company-logo

Redbock - an NES Fircroft company ยท 6 days ago

Senior Biostatistician

positionUnited States
timeContract
remoteRemote
senioritySenior Level
date7+ years exp

Redbock - an NES Fircroft company is seeking a Senior-level Biostatistician contractor to support late-stage clinical development programs, including a pivotal Phase III study in oncology. The role involves providing statistical leadership, overseeing CRO deliverables, and collaborating with cross-functional teams to ensure data integrity and regulatory compliance.

BiotechnologyConsultingMedical DevicePharmaceutical
check
Growth Opportunities
check
H1B Sponsor Likelynote
Hiring Manager
Shanna Blue
linkedin

Responsibilities

Provide statistical leadership and support for a Phase III oncology clinical trial
Oversee statistical deliverables from CRO and external programming teams to ensure accuracy, quality, and regulatory compliance
Review and contribute to statistical analysis plans (SAPs), study protocols, CSR statistical sections, and submission-related documents
Collaborate with internal cross-functional teams and external partners to support data integrity, analyses, and reporting
Perform QC review of statistical outputs, including tables, listings, and figures
Support regulatory submission activities by ensuring timely and high-quality statistical datasets, documentation, and analyses
Serve as a primary statistical point of contact with limited oversight, providing strategic guidance to clinical and regulatory teams

Qualification

BiostatisticsClinical trial designRegulatory submissionsSASStatistical analysis plansCRO managementStatistical conceptsVendor oversightQC processesCommunication skills

Required

M.S. or Ph.D. in Biostatistics, Statistics, or a related discipline
7+ years of biostatistics experience within the biopharmaceutical industry including recent experience with a pharmaceutical sponsor company
Must have experience leading ISS (Integrated Summary of Safety) for oncology clinical trials
Experience supporting or leading regulatory submissions (e.g., NDA/BLA)
Strong knowledge of statistical concepts, clinical trial methodology, and ICH/FDA regulatory guidelines
Proven experience managing CRO deliverables and working with external programming teams
Proficiency in SAS
Strong vendor oversight and data quality review capabilities
Expertise in QC processes for statistical analyses and reporting
Ability to clearly communicate complex statistical concepts to non-statistical stakeholders

Preferred

Early phase clinical trial experience is a plus
Experience with R is a plus

Company

Redbock - an NES Fircroft company

twittertwittertwitter
company-logo
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
dateFounded in 2010
location
Cupertino, California, USA
people-size51-200 employees
web-link
http://redbock.com/

H1B Sponsorship

Redbock - an NES Fircroft company has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired
Company data provided by crunchbase