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.

Key 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.

CRO and Vendor Oversight

• 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.

Additional Responsibilities

• 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 building an efficient, scientifically rigorous, and technology-enabled Biometrics function.

Qualifications & Experience

Required

• PhD in Statistics, Biostatistics, or closely related quantitative discipline.
• 8+ years of relevant biostatistics experience in the pharmaceutical, biotechnology, CRO, or related clinical research environment.
• Strong experience supporting clinical trials and clinical development programs.
• Demonstrated ability to independently lead statistical activities for clinical studies.
• Demonstrated ability to mentor statisticians and contribute to the development of statistical capabilities within the organization.
• Significant experience working with and overseeing CROs or other external statistical service providers.
• Ability to critically evaluate externally produced statistical analyses and deliverables rather than relying solely on vendor review processes.
• Strong knowledge of statistical methods commonly used in clinical development, including longitudinal data analysis, missing-data methodology, multiple imputation, mixed models, categorical data analysis, time-to-event methods, and multiplicity considerations.
• Strong understanding of ICH guidelines and regulatory expectations related to clinical trial design, statistical analysis, and reporting.
• Experience supporting regulatory submissions and health authority interactions.
• Experience supporting scientific publications, abstracts, congress presentations, or advisory board materials.
• Experience developing and reviewing protocols, SAPs, clinical study reports, and regulatory submission documents.
• Experience working with CDISC standards, including SDTM and ADaM, and understanding their relationship to statistical analyses and regulatory submissions.
• Proficiency in statistical programming using R and/or SAS.
• Excellent written and verbal communication skills, including the ability to explain complex statistical concepts to non-statisticians.
• Strong organizational skills and the ability to manage multiple studies, vendors, and competing priorities in a dynamic environment.

Preferred

• Ability to translate statistical findings into clinically meaningful conclusions and development recommendations.
• Experience participating in interactions with FDA, EMA, or other regulatory authorities.
• Experience with obesity, metabolic disease, endocrinology, cardiovascular disease, or related therapeutic areas.
• Experience with estimand frameworks, including treatment-policy and hypothetical strategies, missing-data sensitivity analyses, and other advanced statistical methodologies that are increasingly important in modern clinical development.
• Strong working knowledge of both R and SAS.
• Experience implementing reproducible statistical workflows and using modern analytical or AI-enabled tools to improve efficiency and quality.
• Experience working in a small or rapidly growing biotechnology company.

At Director level, the successful candidate will be expected to provide broader program-level statistical leadership, independently influence clinical development strategy, oversee major CRO statistical activities, mentor more junior colleagues, represent Biostatistics in cross-functional and regulatory discussions, and help shape Biostatistics capabilities as the organization grows.

Personal Attributes

• Scientifically curious and willing to challenge assumptions constructively.
• Comfortable operating in a small biotechnology company where individuals have broad responsibilities.
• Both strategic and willing to work hands-on when needed.
• Highly collaborative while capable of independent decision-making.
• Detail-oriented without losing sight of the larger clinical development objectives.
• Comfortable working directly with CROs and holding external partners accountable for quality and timelines.
• Motivated to help build Biostatistics capabilities and take on broader responsibilities as the organization grows.

Reporting Line

Reports into the Head of Biometrics.

Place of Work

Boston, MA.
Exceptional candidates may be considered for hybrid or remote working arrangements.