Senior Director, Biostatistics

About Us

About the Role

As the Senior Director, Biostatistics you will be responsible for developing and executing on our biostatistics strategy, directly impacting overall success of our clinical programs.

Reporting to the Senior Vice President, Clinical Development, you will execute and oversee modelling and simulation activities in support of the clinical trial designs. You will work closely with internal external partners to help make decisions both operationally and strategically, that impact statistical aspects of clinical development plans of one or more compound/programs. You will participate in meetings with diverse regulatory authorities (FDA, EMA, PEI), assess potential CROs and their proposals from a stats perspective, maintain oversight and provide strategic input on CRO collaboration and/or stats vendors. Experience with IND SAP for Phase II and III, working with and responding to regulatory agencies, and experience with interim analysis are also required.

This is a great opportunity for an experienced Biostatistics leader to join a growing organization and have significant impact. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provide strategic stats inputs for clinical development programs
• Work closely with the medical leads on the assigned trial/s to help design and execute clinical studies.
• Detailed and critical review of historical results and endpoints to optimally integrate into the planned clinical studies
• Multiple simulations and modeling to help inform scenario planning for sample size calculations and other specifics on the assigned trials
• Contribute to regulatory filings and lead (in person, as needed) stats strategy with regulatory agencies  
• Contribute to ongoing medical data review with data management team and critical analysis of emerging data
• Relevant Literature review, and presenting the stats aspects of the clinical development plan to the relevant internal stakeholders.
• Contribute to the protocol development, CRFs and SAPs for the new selected indication/s, working closely with the relevant external and internal stakeholders
• Close oversight over external stats vendors

Experience

• Expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Fluent with other statistical software such as R, EAST, Winbugs is a plus.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with demonstrated leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
• PhD or masters in Biostatistics or equivalent degree
• Experience in managing Biostatics vendors
• Auto-immune and/or neurology clinical study background is a plus
• Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
• Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
• Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
• Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions