Head of Statistical Programming

Alveus Therapeutics is seeking an experienced US based Head of Statistical Programming to establish and lead the Statistical Programming function within our growing Biometrics organization. This is a highly visible leadership position combining hands-on technical programming, functional leadership, vendor oversight, regulatory submission expertise, and development of internal programming standards and infrastructure. The successful candidate will be an experienced statistical programming leader who is comfortable working independently in a small biotechnology environment. The individual will initially operate as both a functional leader and a hands-on programmer while overseeing programming activities performed by CROs and other external partners.

Key Responsibilities

• Establish and lead the Statistical Programming function at Alveus.
• Define programming strategy, operating models, standards, processes, and quality expectations across clinical development programs.
• Serve as the primary Statistical Programming representative within the Biometrics organization and in cross-functional development teams.
• Provide programming leadership from study start-up through database lock, analysis, clinical study reporting, regulatory submission, and post-submission support.
• Develop scalable programming practices appropriate for a growing biotechnology company.

Hands-On Programming

• Perform hands-on SAS programming as needed to support clinical studies, internal analyses, validation activities, and regulatory submissions.
• Independently review and validate SDTM and ADaM datasets, tables, listings, figures, and associated documentation.
• Develop or review complex analysis programs and ensure appropriate implementation of Statistical Analysis Plans.
• Conduct independent programming reviews, validation activities and exploratory analyses to support rapid internal decision-making.
• Troubleshoot complex programming, data, and analysis issues.
• Use R where appropriate for data exploration, visualization, validation, automation, and advanced analytical workflows.

CRO and Vendor Oversight

• Provide technical oversight of CRO and external programming teams.
• Establish clear expectations for deliverables, programming standards, timelines, documentation, validation, and quality.
• Review CRO programming specifications, datasets, programs, outputs, define.xml, reviewer guides, and other submission deliverables.
• Ensure external programming work can be independently understood, reproduced, and appropriately governed by Alveus.
• Identify programming quality or process risks and work with vendors and internal stakeholders to resolve them.
• Participate in vendor selection, qualification, performance assessment, and resource planning.

Regulatory Submissions

• Provide Statistical Programming leadership for regulatory submissions.
• Ensure submission datasets and documentation comply with applicable FDA, CDISC, and regulatory requirements.
• Oversee development, validation, and delivery of SDTM and ADaM datasets, define.xml, SDRG, ADRG, tables, listings, figures, and other required submission components.
• Support responses to regulatory agency questions and preparation of additional analyses or datasets following submission.
• Maintain awareness of evolving regulatory and CDISC standards and implement appropriate changes within the organization.
• Partner closely with Biostatistics, Regulatory Affairs, Clinical Development, and Data Management to ensure submission readiness.

Standards, Systems and Infrastructure

• Develop and maintain Statistical Programming SOPs, work instructions, templates, programming conventions, and validation standards.
• Establish reusable SAS and R tools, macros, functions, templates, and programming libraries where appropriate.
• Partner with the Head of Biometrics and Data Management to develop a secure and regulatory-compliant Biometrics data and programming environment.
• Establish appropriate source-code management, version control, traceability, documentation, access control, and archival practices.
• Support development of internal standards for CDISC implementation and TFL production.
• Evaluate and implement modern technologies, including R, automation, and appropriately governed AI-assisted programming, to improve efficiency while maintaining rigorous validation and quality control.

Qualifications & Experience

Required

• Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or related quantitative discipline.
• Typically, 10+ years of statistical programming experience in the pharmaceutical, biotechnology, CRO, or related clinical research environment.
• Significant experience leading statistical programming activities for clinical development programs.
• Demonstrated experience supporting regulatory submissions, including NDA/BLA or equivalent major global submissions.
• Experience supporting regulatory inspections, audits and data review activities, including preparation and defense of programming deliverables.
• Expert-level proficiency in SAS and extensive experience programming clinical trial data.
• Strong knowledge of CDISC standards, particularly SDTM and ADaM, and associated submission requirements.
• Extensive experience producing and validating tables, listings, figures, analysis datasets, and regulatory submission packages.
• Strong understanding of clinical trial processes and the relationship among protocols, CRFs, databases, SDTM, ADaM, SAPs, and clinical study reports.
• Experience overseeing CROs, external programmers, and other vendors.
• Demonstrated ability to independently assess the quality and technical accuracy of programming deliverables.
• Ability and willingness to remain hands-on technically while providing functional leadership.

Preferred

• Experience working with multiple global health authorities, including FDA, EMA, PMDA, or other major regulatory agencies, with familiarity with agency-specific data and statistical programming expectations.
• Proficiency in R in addition to SAS.
• Experience building or leading a Statistical Programming function within a biotechnology or pharmaceutical organization.
• Experience with obesity, metabolic disease, endocrinology, or other related therapeutic areas.
• Experience with multiple phases of clinical development, including Phase 1 through Phase 3.
• Experience working in small or rapidly growing biotechnology companies.
• Familiarity with modern source-code management and reproducible analytical environments.
• Experience evaluating or implementing AI-assisted programming and automation within a validated or appropriately governed clinical development environment.

Personal Attributes

• A strong technical programmer who has evolved into a leader without losing hands-on expertise.
• Independent, pragmatic, and comfortable making decisions in a small-company environment.
• Highly quality-focused and attentive to reproducibility and traceability.
• Comfortable challenging CRO deliverables and investigating issues directly.
• Collaborative with statisticians, data managers, clinicians, and other development functions.
• Interested in building efficient systems and processes rather than inheriting a large established infrastructure.
• Forward-looking regarding the appropriate use of R, automation, and AI while maintaining rigorous regulatory standards.

Reporting Line

Reports into the Head of Biometrics.

Place of Work

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

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