Head of Statistical Programming & Data Strategy

Alveus Therapeutics group; Boston, Northern (MA, KY); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Alveus Therapeutics seeks an experienced Head of Statistical Programming to establish and lead the programming function within a growing Biometrics team. The role blends hands-on SAS programming with strategic leadership, vendor oversight, and regulatory submissions expertise in a small biotech setting.

You will initially function as both a hands-on programmer and a functional leader, directing CROs and internal staff while shaping standards, infrastructure, and processes for SDTM/ADaM datasets

Qualifications

• 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 pharma/biotech or CRO.
• Significant experience leading statistical programming for clinical development programs.
• Demonstrated experience supporting regulatory submissions, including NDA/BLA or equivalent major global submissions.
• Experience overseeing CROs, external programmers, and other vendors.

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.
• 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.
• 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.
• 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.
• 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.

Skills

Leadership

SAS programming

R programming

Regulatory submissions

Vendor oversight

Education

Bachelor's or Master's degree in Statistics/Biostatistics/CS/Math/Life Sciences

Tools

SAS

R

CDISC SDTM/ADaM

reviewer guides

Job description

Alveus Therapeutics seeks an experienced Head of Statistical Programming to establish and lead the programming function within a growing Biometrics team. The role blends hands-on SAS programming with strategic leadership, vendor oversight, and regulatory submissions expertise in a small biotech setting.

You will initially function as both a hands-on programmer and a functional leader, directing CROs and internal staff while shaping standards, infrastructure, and processes for SDTM/ADaM datasets