Executive Director, Biostatistics

Our client develops small molecule therapeutics with differentiated product profiles for a broad range of cancers.

This role is responsible for managing and leading a team of biostatisticians to support design, analysis and reporting of oncology clinical studies and providing scientifically rigorous statistical expertise on projects and protocols in support for clinical development. Help to maximize the value of clinical data in support of drug development and other scientific strategies. Partner closely within Biometrics with the Head of Statistical Programming and Head of Data Management, and with key stakeholders across Development, Clinical Pharmacology and Translational Medicine. This role is a hands on statistics and programming role as well as a strategic leadership and management role.

Job Responsibilities

• Lead, organize and manage the Biostatistics function
• Set up strong, documented, compliant processes for SAP and mock TFL development
• Lead support for statistical QC of datasets and TFLs
• Responsible (hands on support) for at least one clinical study.
• Oversee, plan, prioritize and project manage statistics objectives, software, timelines and deliverables including annual objectives for the team, weekly/monthly plans
• Provide regular updates to direct line manager and study team leaders on statistics deliverables
• Grow the programming capabilities in R and SAS programming across the team for more flexible and nimble reporting
• Expert in CDISC compliance including SDTM and ADaM dataset production
• Partner closely with the CRO including responsibility for high quality datasets and TFLs.
• Motivate a high quality and flexible analytics mindset where statisticians can execute data visualization and analysis quickly.
• Provide scientifically rigorous statistical expertise on study design, statistical analysis plans interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Provide planning, delivery, and communication of statistical analyses, data presentations and clinical trial results.
• Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.
• Develop effective collaborations internally and externally including, but not limited to, clinical teams, regulatory and industry professionals.
• Ensure all study and project level statistical activities are conducted in compliance with relevant regulatory requirements.
• Provide statistical input and leadership to cross-functional activities, in collaboration with study managers for assigned studies or regulatory submissions.
• Other projects as deemed appropriate.

Job Requirements

• PhD (preferred)/MS in statistics or biostatistics
• A minimum of 15 years of experience in the clinical trial setting; minimum of 8 years of experience in oncology
• Experience in oncology, regulatory submissions in oncology and preparing for advisory committee hearings
• Experience managing people and projects, prioritization and decision making.
• Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations.
• Proven track record of statistical leadership to cross-functional teams at the protocol or project level.
• Strong statistical skills with application to clinical trials including extensive experience with Bayesian, interim analysis and survival analysis methodology.
• Advanced programming skills in SAS and R including data visualization (forest plots, heat maps, box plots, and standard oncology plots)
• Strong verbal and written communication skills.
• Knowledge of drug development process
• Ability to multi-task/ prioritize and time management of daily activities.
• High attention to detail
• Demonstrates high level of accuracy and effective oral and written communication skills.
• Flexibility within a rapidly changing environment
• Excellent ability to work in a goal and team-oriented setting.
• Well-developed organizational skills and the ability to thrive under pressure.