Ardelyx, Inc. · 9 hours ago
Senior Biostatistician
Newark, CA
Full-time
Onsite
Mid, Senior Level
$156K/yr - $188K/yr
2+ years expArdelyx, Inc. is a publicly traded commercial biopharmaceutical company focused on developing innovative medicines. The Senior Biostatistician will provide statistical support for clinical studies, ensuring high-quality deliverables and collaborating with various teams to contribute to regulatory documents and submissions.
BiotechnologyHealth CareMedical
Responsibilities
Work closely with CROs and internal teams across the full trial lifecycle (start-up through close-out) to support trial execution activities and review biometrics deliverables, ensuring high-quality, traceable, and on-time outputs
Review and contribute to key statistical documents (e.g., SAP, statistical monitoring plan, randomization specifications) and ensure alignment with protocol, study objectives, and regulatory expectations
Oversee statistical analyses and ensure the accuracy and quality of statistical deliverables; partner with Statistical Programming on ADaM specifications, TLF shells, outputs, and QC
Provide statistical input to clinical study design, including endpoints, estimands (as applicable), sample size and power calculation, randomization scheme, and analysis methodology
Support the development of publications of Ardelyx study data, including performing ad hoc analyses, review abstracts, posters, and/or manuscripts, and responding to statistical/data-related questions from reviewers
Contribute to regulatory filings and responses, e.g., supporting Regulatory for IND/NDA submissions, responding to statistical/data-related questions in FDA’s Information Request, and supporting PV for safety reporting including PADER and DSUR
Collaborate with the Senior Manager, Biostatistics on statistical research projects and if needed, participates in cross-functional research projects
Partner with Statistical Programming and Data Management to develop and maintain interactive dashboards that provide timely visibility into study progress and key metrics
Qualification
Required
MS or PhD degree in Biostatistics, Statistics, or related discipline with 2 - 7+ years of relevant industry/CRO experience or equivalent experience
Solid understanding of statistical methodologies, drug development process, regulatory requirements related to trial design, analysis, and reporting
Experience with CDISC standards (SDTM/ADaM) and study-level statistical deliverables, including SAP development, TFL review/QC, and review of clinical or regulatory documents involving clinical trial data
Proficiency working with statistical software; SAS experience strongly preferred. Experience with R/Python and data visualization tools (e.g., R Shiny, Tableau, Power BI) is a plus
Strong written and verbal communication skills, with the ability to explain statistical concepts to non-statistical audiences
Ability to establish and manage timelines, prioritize effectively and deliver accurate, high-quality biometrics outputs on schedule
Benefits
401(k) plan with generous employer match
12 weeks of paid parental leave
Up to 12 weeks of living organ and bone marrow leave
Equity incentive plans
Health plans (medical, prescription drug, dental, and vision)
Life insurance and disability
Flexible time off
Annual Winter Holiday shut down
At least 11 paid holidays
Company
Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.
201-500 employees
H1B Sponsorship
Ardelyx, Inc. 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 (1)
2024 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$557.68MKey Investors
HealthCare Royalty PartnersSLR Capital PartnersNew Enterprise Associates
2022-06-30Post Ipo Debt· $20M
2022-02-24Post Ipo Debt· $27.5M
2019-12-12Post Ipo Equity· $125M
Leadership Team
Mike Raab
President & CEO
Elizabeth Grammer
Chief Legal and Administrative Officer
Recent News
GlobeNewswire
2026-01-23
2026-01-20
2026-01-20
Company data provided by crunchbase