Role 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. 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 Qualifications
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 Education
MS or PhD degree in Biostatistics, Statistics, or related discipline with 2 - 7+ years of relevant industry/CRO experience or equivalent experience
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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. 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 Qualifications
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 Education
MS or PhD degree in Biostatistics, Statistics, or related discipline with 2 - 7+ years of relevant industry/CRO experience or equivalent experience
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