Associate Director or Director, Biostatistics
Job Description
Join MindMed: Leading the Future of Brain Health
At MindMed, we’re pioneering innovative treatments for brain health disorders, driven by a mission to revolutionize patient outcomes. As a clinical-stage biopharmaceutical company, we’re expanding our global footprint and seeking passionate, high-impact individuals to join our team. If you’re a patient-centric, driven professional looking to contribute to groundbreaking advancements, we invite you to explore this exciting opportunity.
Associate Director/Director of Biostatistics: Shape the Future of Clinical Development
MindMed is seeking a talented and experienced Associate Director or Director of Biostatistics to provide crucial statistical leadership for our clinical development programs. Reporting to the Vice President, Head of Biometrics and Data Science, you will play a pivotal role in shaping our pipeline compounds’ journey from clinical trials to regulatory filing and commercialization.
This hands-on role offers the opportunity to lead statistical activities for assigned clinical programs and/or clinical trials, providing leadership from trial design and data analysis to results interpretation and dissemination. You will be responsible for ensuring the quality of statistical deliverables in collaboration with multi-functional project teams, and will also manage statistical vendors and contribute to data cleaning activities.
Key Responsibilities
- Provide statistical input to the creation of clinical development plan for the assigned compound(s) (for the Director role)
- Collaborate with cross-functional experts on clinical trial designs and contribute to determining objectives, endpoints, and sample size.
- Author the statistical methods section in protocols and review protocols, as an integral part of the protocol development team.
- Ensure the accuracy of the randomization algorithm and contribute to eCRF design.
- Own the study statistical analysis plan (SAP), create table/figures/listing (TFL) shells.
- Manage statistical vendors to implement the SAP and deliver study results with quality and speed.
- Manage statistical vendors to deliver data analyses as needed (e.g., DMC support, interim analysis).
- Provide statistical input to data reporting and external dissemination, including clinical study reports, regulatory communications, and publications.
- Conduct data analyses using SAS programs in collaboration with the Statistical Programming group.
- Contribute to the development of Biometrics’ SOPs (for the Director role).
Requirements (Associate Director)
- PhD in Statistics, Biostatistics, or related field.
- 7+ years of experience in the pharmaceutical or biotechnology industry.
- Solid knowledge of statistical methods and clinical trial design.
- Experience in authoring SAPs and TFL shells.
- Proven experience managing statistical vendors.
- Proficiency in SAS for data analysis.
- Knowledge of relevant regulatory guidance.
- Demonstrated collaboration skills.
- Strong organizational and project management skills.
- Detail-oriented with high standards.
- Excellent communication and interpersonal skills.
Requirements (Director)
- PhD in Statistics, Biostatistics, or related field.
- 10+ years of experience in the pharmaceutical or biotechnology industry.
- Strong track record of using statistical methods to solve problems in clinical trials.
- All qualifications and skills required for the Associate Director role.
Preferred Experience
- Experience in CNS drug development from clinical trials design to data analysis.
- Experience in regulatory filing and submission dossier preparation.
Compensation & Benefits
The starting base pay range for this position at the Associate Director level is $184,662.00 – $204,672.00. The starting base pay range for this position at the Director level is $210,000.00 – $235,032.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
MindMed offers a comprehensive benefits package including:
- 100% paid health benefits for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave
Explore our Jobs Page for complete details.
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