Director, Statistical Programming

X4 Pharmaceuticals • Boston, MA

4d

About The Position

X4 Pharmaceuticals seeks a Director, Statistical Programming to oversee statistical programming across its portfolio and support clinical trials and regulatory submissions. Reporting to the Senior Director, Biostatistics, this role manages CROs, provides hands-on programming support and technical guidance, builds and maintains programming infrastructure, and ensures compliance with SOPs and quality standards. The position applies SAS and CDISC SDTM and ADaM standards to produce analysis datasets, tables, figures, listings, and files for electronic submissions in eCTD format. It also contributes to technology development and process improvement initiatives.

Requirements

• Master’s degree in Statistics, Computer Science, or a related field and at least 8 years of SAS programming experience in the pharmaceutical or biotech industry; alternatively, a bachelor’s degree in one of these fields and at least 10 years of such experience.
• Proven experience independently leading statistical programming activities for regulatory submissions.
• Demonstrated ability to manage CRO relationships and oversee programmed deliverables.
• Experience supporting statistical programming for early- and late-phase clinical trials and regulatory submissions, including NDA and MAA.
• Strong hands-on SAS programming skills.
• In-depth knowledge of CDISC SDTM and ADaM standards and FDA electronic data submission requirements.
• Experience developing programming specifications, integrated summary safety and efficacy datasets and analyses, and eCTD electronic submission data packages.
• Familiarity with statistical analysis methods and clinical data management concepts.
• Deep knowledge and experience with FDA and GCP/ICH regulations and guidelines.
• Ability to manage multiple projects, conflicting priorities, and changing priorities.
• Excellent written and verbal communication, organizational, and documentation skills.
• Excellent attention to detail and problem-solving skills.
• Proven project management skills, a professional attitude, a self-improvement mentality, and a positive attitude.

Responsibilities

• Oversee statistical programming activities across X4’s portfolio, internally and through CROs, and act as project manager for programming deliverables.
• Provide hands-on SAS programming support and technical guidance for clinical trials and regulatory submissions.
• Design and develop SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH, and SAS macros.
• Develop and deliver CDISC- and regulatory-compliant SDTM and ADaM datasets.
• Develop and execute statistical analysis and reporting deliverables, including tables, figures, and listings, in a timely and high-quality manner.
• Provide input into the design and development of case report forms and clinical study databases.
• Collaborate with cross-functional teams to support clinical trial analysis and reporting through regulatory approval and product launch.
• Assess and perform quality-control checks and validation of SAS code and output from vendors or other statistical programmers for SDTM datasets, ADaM datasets, and tables, figures, and listings.
• Author and review SDTM and ADaM dataset specifications.
• Create and review eCTD documents for regulatory submission packages.
• Provide programming support for integrated summary safety and efficacy datasets and analyses.
• Participate in the development and review of relevant SOPs.
• Participate in departmental and cross-functional technology development and process improvement initiatives.
• Manage multiple projects and changing or conflicting priorities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director