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Biostatistician
Job Location:
Job Location:
Newark, DE - USA
Monthly Salary:
$ 124000 - 152000
Monthly Salary:
Posted:
18 May 2026 (30+ days ago)
Posted:
Application Deadline:
15 August 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Position Summary:
The 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.
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 FDAs 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.
Qualifications:
- MS or PhD degree in Biostatistics Statistics or related discipline with up to 2 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
The anticipated annualized base pay range for this full-time position is $124000-$152000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
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.
Ardelyx is an equal opportunity employer.
Required Experience:
IC
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
