Senior Biostatistician

Description

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:

• 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.

• 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