Director, Biostatistics

Stratacuity: Proven Scientific Placement; Waltham (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Stratacuity: Proven Scientific Placement's Waltham-based client seeks a Director of Biostatistics to provide strategic and hands-on statistical leadership across clinical programs. The role emphasizes study design, data analysis, regulatory support, and cross-functional collaboration to advance innovative therapies.

The position requires a PhD in Biostatistics or related field (or an MS with substantial industry experience) and strong expertise in trial design, SAPs, and regulatory interactions.

Qualifications

• PhD in Biostatistics or related field (or Master's with substantial industry experience).
• Experience supporting clinical development programs in biotechnology or pharmaceutical settings.
• Strong knowledge of trial design, statistical methods, and regulatory requirements.
• Experience developing SAPs and supporting studies through key development milestones.
• Proficiency with R and SAS or similar statistical tools.
• Excellent communication skills to translate complex statistics for diverse audiences.

Responsibilities

• Lead statistical strategy and provide biostatistical support across clinical studies.
• Design, analyze, and interpret trial data to support development decisions.
• Develop study designs, statistical methodologies, and analysis plans.
• Author and review SAPs, statistical outputs, and clinical study reports.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and external partners.
• Provide oversight of external CROs, biostatistics vendors, and programming activities.
• Support regulatory submissions and health authority interactions as needed.
• Generate clear and impactful presentations, visualizations, and statistical summaries for stakeholders.
• Contribute to the integration and interpretation of clinical, safety, and biomarker data.

Skills

Biostatistics expertise

Clinical trial design

Regulatory knowledge

Statistical programming (R/SAS)

Communication skills

Collaboration

Education

PhD in Biostatistics or related field

Master's degree with equivalent experience

Tools

R

SAS

Job description

Director, Biostatistics (Waltham, MA- Hybrid Onsite)

Our Waltham based biotech client is seeking an experienced Director of Biostatistics to provide strategic and hands-on statistical leadership across clinical development programs. This individual will play a key role in study design, data analysis, regulatory support, and cross-functional collaboration, helping advance innovative therapies through clinical development.

Responsibilities

• Lead statistical strategy and provide biostatistical support across clinical studies.
• Design, analyze, and interpret clinical trial data to support development decisions.
• Develop study designs, statistical methodologies, and analysis plans.
• Author and review Statistical Analysis Plans (SAPs), statistical outputs, and clinical study reports.
• Collaborate with Clinical Development, Data Management, Regulatory Affairs, Medical Affairs, and external partners.
• Provide oversight of external CROs, biostatistics vendors, and programming activities.
• Support regulatory submissions and health authority interactions as needed.
• Generate clear and impactful presentations, visualizations, and statistical summaries for internal and external stakeholders.
• Contribute to the integration and interpretation of clinical, safety, and biomarker data.

Qualifications

• PhD in Biostatistics, Statistics, or a related quantitative discipline with significant industry experience, or Master's degree with equivalent experience.
• Demonstrated experience supporting clinical development programs within biotechnology or pharmaceutical organizations.
• Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements.
• Experience developing SAPs and supporting clinical studies through key development milestones.
• Proficiency with R, SAS, or other statistical programming tools.
• Excellent communication skills with the ability to translate complex statistical concepts for technical and non-technical audiences.
• Experience working in a collaborative, fast-paced environment.