We are seeking an experienced Senior Director of Biostatistics to lead and shape the biostatistical strategy for clinical trials within this dynamic organization. You will play a critical role in overseeing statistical design, data analysis, and regulatory submissions, working closely with cross-functional teams in clinical development, data management, and regulatory affairs. As a senior leader, you will also mentor junior staff and drive innovations in trial design and statistical methodologies.
Key Responsibilities:
- Lead the statistical strategy for clinical trials, from Phase I through Phase III, primarily focusing on oncology and autoimmune indications.
- Collaborate with clinical, regulatory, and medical affairs teams to ensure robust statistical planning, analysis, and reporting.
- Oversee statistical contributions to study protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
- Ensure compliance with regulatory guidelines and industry best practices in statistical methodologies.
- Provide leadership and mentorship to biostatistics team members.
- Contribute to regulatory submission processes, including interactions with the FDA and EMA.
- Champion the use of innovative trial designs and statistical approaches in clinical development.
Key Qualifications:
- Ph.D. or Master’s in Biostatistics, Statistics, or a related field.
- 5+ years of experience in biostatistics, with at least 5 years in a leadership role within the biotech or pharmaceutical industry.
- Extensive experience in oncology and/or autoimmune disease therapeutic areas.
- Proven expertise in statistical methods for clinical trials, including adaptive designs and Bayesian methods.
- Strong understanding of regulatory requirements (FDA, EMA) and experience with submissions.
- Excellent communication skills, with the ability to translate complex statistical concepts into actionable insights for cross-functional teams.
- Passion for mentoring and developing biostatistics talent.
