Axsome Therapeutics is seeking a Director, Biostatistics to support the development of new therapies and ensure the integrity and accuracy of statistical analyses for clinical trials.
Requirements
- Proficiency in statistical software (e.g., SAS, R) and data management tools
- Strong understanding of clinical trial design, statistical methodologies, and regulatory requirements
- Experience leading statistical strategy across multiple clinical development programs
- Expertise in designing complex clinical trials, including pivotal studies
- Knowledge of Good Clinical Practice (GCP) and regulatory guidelines
- Direct experience in preparing statistical content for regulatory submissions (e.g., INDs, NDAs, MAAs)
Responsibilities
- Oversee and manage CRO (statistics and data management) activities
- Lead or supervise statistical activities in the design, analysis and reporting of all phases of clinical trials
- Prepare statistical sections of clinical study reports, regulatory submissions, and publications
- Analyze, interpret, and present statistical results to internal and external stakeholders
- Ensure the accuracy and integrity of data through rigorous quality control procedures
- Participate in cross-functional meetings and contribute to strategic planning
- Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs)
Other
- Master’s degree with at least 12 years of experience or PhD with at least 8 years of experience in Biostatistics within the pharmaceutical or biotechnology industry
- Excellent communication and presentation skills
- Ability to work collaboratively in a team environment
- Ability to work on-site Monday, Tuesday, and Thursday
- Leadership and CRO management skills
- Attention to detail and commitment to quality
- Ability to manage multiple projects and meet deadlines
