Associate Director, Biostatistics (Oncology)

Location: Remote for US-based candidates; Palo Alto, California

Base salary for US-based candidates: $172,000–$258,000 per year, plus potential bonus, equity, and benefits.

Company

hirify.global is a global biopharmaceutical company developing medicines for serious diseases, with a focus on oncology, neuroscience, sleep disorders, and epilepsy.

What you will do

• Lead statistical strategy, study design, analyses, and reporting for Phase I–IV clinical trials and drug development projects.
• Develop and review statistical analysis plans, interpret clinical data, and prepare data displays.
• Develop statistical programs for trial simulations, analyses, data validation, and verification of statistical programming outputs.
• Collaborate with clinicians, data managers, biostatisticians, statistical programmers, researchers, and external thought leaders.
• Support regulatory agency meetings, respond to statistical questions, and contribute to NDA or BLA submissions.
• Recruit, develop, and supervise internal and external statisticians and manage external statistics and programming vendors.

Requirements

• PhD with more than 4 years of experience or MS with more than 6 years of experience in statistics, mathematics, or a related discipline with a statistical focus.
• Strong knowledge of clinical trial design, statistical inference, complex statistical methods and models, and Phase II–IV clinical trial analysis.
• Good knowledge and experience in oncology; hematology experience is preferred.
• Experience with SAS or R, proficient SAS programming skills, and comprehensive knowledge of CDISC SDTM and ADaM standards.
• Thorough knowledge of ICH guidelines and drug development regulatory requirements related to statistical analysis.
• Excellent written and verbal communication, interpersonal, leadership, research, organization, and time-management skills.

Nice to have

• Bayesian and adaptive trial design experience.
• Experience contributing to NDA or BLA submissions and regulatory defense.
• Knowledge of additional statistical applications and programming languages.

Culture & Benefits

• Work in a fast-paced, flexible, and team-oriented environment.
• Collaborate across clinical development, biometrics, regulatory, and research functions.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan and flexible paid vacation.
• Potential annual cash bonus or incentive compensation and discretionary equity grants.