Head of Biostatistics Automation (SME Lead)
This role will guide the translation of biostatistical and statistical programming workflows into structured automation logic within the product. You will manage a team of senior statistical programmers and biostatistics SMEs responsible for developing the domain “skills” that power the automation engine.
Working closely with engineering and product leadership, you will ensure the platform reflects customer needs and integrates easily into real-world clinical trial workflows while delivering meaningful automation across SAP development, dataset specifications, code, and analysis outputs.
SME Team Leadership
- Build and manage a team of biostatistics and statistical programming SMEs responsible for developing domain skills.
- Oversee the creation of reusable automation logic across SAP components, dataset definitions, code, and analysis outputs.
- Establish quality and validation processes for SME-generated content.
Product Collaboration
- Partner closely with engineering and product teams to translate domain requirements into product features.
- Help prioritize roadmap items based on automation impact and workflow value, including core modules and supportive features (independent validation workflows, replicate code into additional languages, aCRF automation, pooled analyses, etc.).
- Provide detailed specifications and iterative feedback during development cycles.
Automation Skill Development and Industry Alignment
- Guide the development of modular automation skills that encode statistical workflows and decision logic.
- Ensure outputs are operationally realistic and consistent with industry practice.
- Maintain awareness of evolving regulatory expectations and clinical trial statistical practices.
- Ensure platform outputs remain compliant and credible for sponsors and regulators.
Requirements
- Experience leading biostatistics or statistical programming teams within clinical trials.
- Ability to recruit and oversee teams with deep expertise in:
- Statistical Analysis Plans (SAPs)
- Specifications and programming SDTM / ADaM datasets
- TLF programming
- CDISC standards
- Clinical trial statistical workflows
- Leadership experience managing statistical programming or biostatistics teams.