Director Biostatistics

Alveus Therapeutics is seeking an experienced and highly motivated Biostatistician at Director level to join our growing Biometrics organization. This individual will support clinical development programs and work closely with Clinical Development, Data Management, Statistical Programming, Regulatory Affairs, Clinical Operations, and external partners. The successful candidate will provide statistical leadership across clinical studies, from study design and protocol development through analysis, interpretation, regulatory submissions, and publication.

In addition, this individual will play an important role in overseeing statistical work performed by CROs and other external vendors, ensuring that deliverables meet Alveus standards for scientific rigor, quality, consistency, and regulatory compliance. As Alveus grows, the role will have opportunities to assume broader program-level and functional responsibilities.

• Serve as the primary statistician for assigned clinical development programs and/or studies.
• Provide statistical leadership for clinical development strategy, including study design, endpoint selection, estimand strategy, sample size determination, randomization, interim analyses, and statistical analysis methodology.
• Lead the development and review of statistical sections of clinical study protocols, Statistical Analysis Plans (SAPs), study specifications, and other key clinical documents.
• Develop appropriate statistical methodologies for efficacy, safety, pharmacodynamic, and other clinical endpoints.
• Provide statistical input into handling missing data, intercurrent events, sensitivity analyses, multiplicity, subgroup analyses, and other complex statistical issues.
• Work closely with Clinical Development and other cross-functional colleagues to ensure that study objectives and statistical approaches are scientifically sound and operationally feasible.
• Review and interpret clinical study results and contribute to clinical study reports, regulatory documents, presentations, publications, and other scientific communications.
• Provide statistical leadership and support for interactions with regulatory agencies, including preparation of briefing documents, health authority responses, and submission-related analyses.

• Provide statistical oversight of CROs and other external partners supporting clinical development activities.
• Serve as the primary statistical point of contact for assigned CRO statistical teams.
• Review and approve CRO-developed statistical deliverables, including protocols, SAPs, mock shells, analysis specifications, datasets, tables, listings, figures, and clinical study report outputs.
• Ensure CRO statistical analyses are implemented in accordance with the protocol, SAP, applicable regulatory guidance, and Alveus standards.
• Critically review statistical programming and analysis results produced by CROs and independently investigate discrepancies or unexpected findings when necessary.
• Partner closely with Statistical Programming and Data Management to ensure alignment across data collection, analysis datasets, statistical methods, and reporting.
• Establish clear expectations for CRO deliverables, timelines, quality standards, documentation, and issue resolution.
• Monitor CRO performance and proactively identify statistical, operational, or quality risks.
• Participate in vendor selection, qualification, governance, and performance evaluation as appropriate.
• Ensure sufficient internal knowledge and documentation are maintained so that statistical analyses can be understood, reproduced, and defended independently of the CRO.

• Collaborate closely with Statistical Programming and Data Management to ensure the quality and traceability of analysis datasets, tables, listings, figures, and other statistical outputs.
• Perform or independently reproduce statistical analyses using R and/or SAS when appropriate to support internal review, validation, exploratory analyses, and decision-making.
• Contribute to the development of internal statistical standards, processes, tools, and best practices within the Biometrics organization.
• Provide statistical input into broader clinical development and program-level decision-making.
• Support preparation of regulatory submission materials and responses to health authority questions.
• Stay current with evolving regulatory guidance, statistical methodology, and best practices relevant to clinical drug development.
• Contribute to…