Associate Director, Biostatistics

Sironax Ltd.; Waltham (MA); Hybrid; USD 130,000 - 160,000; Full time

Job summary

Sironax Ltd. is looking for a motivated Associate Director, Biostatistics to significantly influence clinical trial designs and regulatory strategy. This role combines strategic oversight with analytical expertise in a collaborative environment.

The ideal candidate will have extensive experience in biostatistics within the biotech sector, offering support across diverse clinical development programs. The position requires adaptability and strong communication skills to work globally across teams.

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.

Responsibilities

• Provide statistical ownership for design, conduct, analysis, and reporting of clinical trials.
• Serve as lead biostatistician on assigned clinical programs.
• Collaborate with cross-functional teams to align statistical strategy.

Skills

Biostatistical analysis

SAS programming

R programming

Regulatory submission knowledge

Leadership

Education

Master’s or Ph.D. in Statistics, Biostatistics, or related

Tools

SAS

R

Job description

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.