Associate Director, Biostatistics

Accountabilities:

Lead biostatistical activities for clinical oncology development programs, developing and implementing statistical strategies, study designs, and analytical approaches aligned with clinical and regulatory objectives.
Provide statistical leadership across all phases of clinical development, including early-phase dose finding, dose optimization, pivotal trials, and registration-oriented studies.
Support interactions with global health authorities, including the FDA and EMA, by preparing statistical briefing materials, responding to agency questions, and contributing to regulatory submission packages.
Author and maintain key statistical documentation, including statistical sections of clinical trial protocols, Statistical Analysis Plans (SAPs), and Tables, Listings, and Figures (TLF) shells.
Collaborate with multidisciplinary clinical development teams to ensure statistical deliverables, analytical objectives, and study milestones remain aligned and on schedule.
Identify, investigate, and resolve statistical and data analysis challenges affecting clinical trials, regulatory submissions, and development decisions.
Review and validate study documentation, statistical programming outputs, vendor deliverables, and analysis results to ensure accuracy, consistency, quality, and regulatory compliance.
Work closely with statistical programmers to support regulatory requests, Development Safety Update Reports (DSURs), Investigator's Brochures (IBs), scientific publications, and ad hoc analyses.
Participate in the ongoing review of clinical trial data, evaluating data integrity and identifying emerging efficacy, safety, and other clinically relevant trends.
Apply advanced statistical methods, including Bayesian approaches and simulation techniques, to support robust trial design and evidence generation.
Oversee external vendors and biometrics service providers, ensuring deliverables meet agreed timelines, quality expectations, and applicable regulatory standards.
Explore, pilot, and support the implementation of AI-enabled tools and workflows to improve statistical quality control, streamline operations, and increase productivity.
Maintain compliance with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, applicable regulatory requirements, and internal standard operating procedures.
Communicate statistical findings and recommendations clearly to technical and nontechnical stakeholders, influencing decisions through rigorous analysis and evidence-based insights.
Travel approximately 10% of the time and accommodate occasional evening or weekend work when required to support critical study milestones and deliverables.
Requirements:
Advanced degree in Statistics or Biostatistics, with a PhD and at least six years of relevant industry experience, or a master's degree and at least eight years of relevant experience.
Substantial biostatistics experience within the pharmaceutical or biotechnology industry, particularly in clinical drug development.
Demonstrated experience supporting oncology clinical trials, with an in-depth understanding of statistical methods relevant to cancer research and clinical development.
Practical experience applying Bayesian statistical methods in a clinical development setting.
Strong knowledge of clinical trial design, statistical analysis methodologies, dose-finding strategies, and interpretation of clinical data.
Proficiency in statistical software such as SAS, R, and EAST, including the use of simulation techniques for clinical trial design.
Working knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), with the ability to review and interpret statistical outputs.
Experience authoring and reviewing statistical analysis plans, protocol documentation, TLF shells, and other clinical development and regulatory deliverables.
Understanding of GCP, ICH guidelines, and global regulatory requirements, with the ability to contribute to regulatory submissions and health authority interactions.
Proven ability to oversee external vendors and ensure the accuracy, timeliness, quality, and compliance of statistical and biometrics deliverables.
Strong analytical, critical-thinking, and problem-solving skills, with meticulous attention to detail and a commitment to scientific rigor and data integrity.
Excellent written and verbal communication skills, including the ability to explain complex statistical concepts and collaborate effectively with multidisciplinary teams.
Demonstrated leadership and stakeholder management capabilities, with the ability to influence decisions, coordinate priorities, and deliver results in a highly regulated environment.
Preferred: Experience in radiopharmaceutical therapy (RPT) or radiopharmaceutical imaging (RPI) drug development.
Preferred: Experience preparing or contributing to global regulatory submissions and responding to health authority requests.
Preferred: Experience with innovative clinical trial designs, including adaptive trial methodologies.
Preferred: Experience using AI-enabled tools to improve statistical workflows, operational efficiency, and quality control.
Ability to manage competing priorities, work independently in a remote setting, and adapt to evolving clinical development needs.
Ability to meet the physical requirements of the role, including prolonged periods of sitting, reaching, and communicating, as well as occasional lifting or moving of items weighing up to 20 pounds.
Benefits:
Annual base salary: $173,217–$209,899 for the remote position in the United States, depending on relevant skills, experience, work location, and other applicable factors.
Additional compensation: Potential eligibility for discretionary cash incentives and stock-based compensation opportunities.
Comprehensive healthcare coverage: Medical, dental, and vision insurance, subject to applicable plan terms.
Retirement and financial protection: Access to retirement savings programs and financial protection benefits.
Insurance coverage: Life and disability insurance options.
Flexible paid time off: Eligible U.S.-based exempt employees receive Flexible Time Off (FTO) without a fixed accrual limit, subject to manager approval.
Paid holidays: 11 company holidays annually.
Vacation benefits: Eligible non-exempt employees and certain other employee groups receive 160 hours of paid vacation annually for new hires, subject to applicable policies, along with 11 company holidays and three optional holidays.
Additional leave options: Depending on eligibility, benefits may include paid sick leave, parental and caregiver leave, medical and personal leave, bereavement leave, and military leave.
Volunteer opportunities: Eligible employees may receive up to two paid volunteer days per year.
Work-life balance: Potential access to summer hours flexibility and an annual company-wide shutdown between Christmas Day and New Year's Day, subject to eligibility and applicable policies.
Remote work flexibility: The opportunity to work remotely within the United States while collaborating with multidisciplinary clinical development teams.
Scientific and professional growth: Opportunities to expand expertise in advanced biostatistics, oncology research, radiopharmaceutical development, and global regulatory strategy.
Meaningful impact: The opportunity to contribute to the development of innovative cancer therapies and help generate evidence that supports better outcomes for patients.