Director, Biostatistics
Apex Systems
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.
Vacancy posted 1 day ago
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