Senior Biostatistician

Ardelyx•Newark, CA

7d•$156,000 - $188,000

About The Position

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Senior Biostatistician will provide hands-on statistical support and contribute to key statistical activities for clinical studies, including analysis planning, oversight of statistical deliverables, interpretation of results, and contributions to regulatory documents and submissions. This position works closely with Clinical, Data Management, Statistical Programming, Medical/Safety, and Regulatory to deliver high-quality, submission-ready outputs.

Requirements

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.
Strong written and verbal communication skills, with the ability to explain statistical concepts to non-statistical audiences
Ability to establish and manage timelines , prioritize effe ctively and deliver accurate, high-quality biometrics outputs on schedule

Nice To Haves

Experience with R/Python and data visualization tools (e.g., R Shiny, Tableau, Power BI) is a plus

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.

Benefits

Ardelyx also offers a robust benefits package to employees, including a 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, and at least 11 paid holidays.

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