Associate Director, Biostatistics

Summary

Join MindMed, a clinical-stage biopharmaceutical company, as an Associate Director or Director of Biostatistics. This role provides statistical support for clinical development, regulatory filing, and commercialization of pipeline compounds. You will serve as the lead biostatistician for assigned programs and trials, leading from design and analysis to interpretation and dissemination. Responsibilities include ensuring high-quality statistical deliverables, collaborating with multi-functional teams, and overseeing vendor deliverables. You will perform statistical analyses using SAS and partner with the Clinical Data Management group. The position offers a competitive salary and benefits package.

Requirements

• A PhD degree in Statistics, Biostatistics or relevant fields with at least 7 years’ working experience in the pharmaceutical or biotechnology space
• Solid statistical knowledge and experience in clinical trial design (early to late phase), data analysis, and reporting
• Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions
• Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
• Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
• Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
• Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
• Strong organizational and project management skills; demonstrated interest in continued learning and growth
• Detail-oriented and hold high standards of excellence for own work products
• Deliver and communicate effectively in the work-from-home environment
• Excellent interpersonal skills and is a good team player
• A PhD degree in Statistics, Biostatistics or relevant fields with at least 10 years’ working experience in the pharmaceutical or biotechnology space
• Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement
• All qualifications and skills required for Associate Director role

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 make contributions to determination of objectives, endpoints and sample size
• Play as an integral part of a protocol development team by authoring statistical methods section and reviewing the protocol throughout
• Ensure the accuracy of randomization algorithm and contribute to eCRF design to ensure data collection’s alignment with study objectives
• Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
• Hold the primary responsibility of working with statistical vendors to implement the SAP and deliver study results with quality and speed
• Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
• Conduct data analyses as needed by using own SAS programs in collaboration with Statistical Program group for validation
• Contribute to the development of Biometrics’ SOPs (for the Director role)

Preferred Qualifications

• Experience in CNS drug development from clinical trials design to data analysis
• Experience in regulatory filing from integrated data analysis planning and execution to submission dossier preparation

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!