Sr. Manager​/Associate Director, Statistical Programming

Position Summary

The Senior Manager / Associate Director, Statistical Programming will provide strategic and operational leadership for statistical programming activities across one or more clinical development programs. This individual will be responsible for the planning, execution, oversight, and delivery of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision‑making. The successful candidate will serve as a key partner to Biostatistics, Clinical Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and external vendors to ensure high‑quality, compliant, and timely programming deliverables.

This role offers the opportunity to influence programming standards, mentor team members, and contribute to the continued growth of Avalo’s Biometrics organization.

• Lead statistical programming activities for one or more clinical studies, programs, or therapeutic areas.
• Provide strategic oversight and accountability for the development, validation, and delivery of statistical programming outputs, including SDTM and ADaM data packages (SDRG, ADRG, Define.xml, submission‑ready datasets), and Tables, Listings, Figures (TLFs).
• Ensure programming deliverables meet quality, timeline, regulatory, and audit‑readiness requirements.
• Support regulatory submissions, health authority interactions, publications, and ad hoc analyses.

• Manage and oversee outsourced statistical programming activities conducted by CROs and external partners.
• Review and validate datasets, TLFs, specifications, and programming documentation generated by vendors.
• Monitor vendor performance, timelines, quality metrics, and resource allocation to ensure successful project execution.
• Establish and maintain effective partnerships with external programming and biometrics vendors.

• Partner closely with Biostatistics, Data Management, Clinical Operations, Medical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and other stakeholders to deliver high‑quality clinical data and analyses.
• Review and provide programming input on Protocols, Statistical Analysis Plans (SAPs), Data Management Plans (DMPs), CRFs, annotated CRFs, data review plans, and dataset and TLF specifications.
• Collaborate on the development of data review tools, dashboards, visualizations, and other statistical applications to support clinical development activities.
• Communicate programming strategies, timelines, risks, and resource needs to project teams and leadership.

• Contribute to the development, implementation, and continuous improvement of internal statistical programming standards, processes, and best practices.
• Assist with establishing framework of programming environment, including library of macros.
• Drive adoption of CDISC standards, programming automation, and innovative analytical solutions.
• Maintain expertise in regulatory requirements, industry standards, and emerging technologies related to statistical programming.
• Support inspection readiness and represent Statistical Programming during audits and regulatory inspections as needed.

• Mentor, coach, and develop junior statistical programmers to support individual growth and organizational success.
• Provide leadership and technical guidance to internal and external programming teams.
• Participate in recruiting, onboarding, and developing programming talent.
• Foster an inclusive, collaborative, and psychologically safe environment that encourages innovation, learning, and accountability.

• Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related quantitative discipline. Bachelor’s degree with significant relevant experience will also be considered.
• Sr Manager: 7+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry;
  Associate Director: 9+ years of experience.
• Demonstrated experience serving as a lead programmer…