Associate Director, Biostatistics

This role requires 3 days per week in Waltham, MA office

Sironax is seeking a highly motivated and experienced Associate Director, Biostatistics to play a critical role within our global clinical development organization. This position combines strategic statistical ownership with hands-on analytical expertise, offering a unique opportunity to influence clinical trial design, regulatory strategy, and corporate milestones.

The ideal candidate is adaptable, collaborative, and thrives in a fast-paced biotech environment. You will provide statistical support across clinical development programs while also supporting high-priority internal analyses, executive presentations, and regulatory reporting activities across multiple therapeutic areas, including rare diseases.

Key Responsibilities

• Provide statistical ownership for the design, conduct, analysis, and reporting of clinical trials, including protocol development, statistical analysis plans (SAPs), and sample size and power calculations.
• Serve as lead biostatistician on assigned clinical programs, partnering with cross-functional teams to align statistical strategy with overall development goals.
• Lead oversight and management of CROs and external vendors to ensure timely, high-quality, and scientifically sound biostatistics deliverables.
• Collaborate closely with cross-functional teams including Statistical Programming, Clinical Operations, Data Management, Regulatory Affairs, and Investor Relations.
• Maintain alignment across global teams, including effective collaboration with US- and China-based stakeholders across multiple time zones.
• Ensure compliance with CDISC standards, ICH guidelines, and FDA/EMA regulatory requirements.
• Author and review statistical sections of protocols, SAPs, clinical study reports, and regulatory submission documents.
• Provide statistical input for regulatory interactions, including briefing documents and responses to health authority queries.
• Support biostatistics activities across a diverse clinical pipeline, including complex and data-limited rare disease programs.
• Contribute to process improvement initiatives, statistical standards, and operational efficiencies within the biostatistics function.

Qualifications

• Master’s or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline.
• Minimum of 8 years of biostatistics experience within the biotechnology or pharmaceutical industry.
• At least 2 years of leadership, vendor oversight, or project management experience.
• Advanced proficiency in SAS and/or R programming for statistical analysis; hands-on analytical capability strongly preferred.
• Strong knowledge of CDISC standards (SDTM and ADaM), ICH guidelines, and regulatory submission requirements.
• Experience supporting regulatory submissions and corporate milestones such as investor presentations or fundraising activities is preferred.
• Excellent communication and collaboration skills with the ability to work effectively in a global environment.

What We’re Looking For

• A proactive biostatistician who is comfortable balancing strategic oversight with hands-on execution.
• An agile and adaptable professional who thrives in dynamic, fast-moving environments.
• A collaborative team player with experience managing global stakeholders and cross-functional partnerships.
• A solution-oriented thinker capable of navigating the unique challenges associated with rare disease clinical development.