Sr Director, Statistical Innovation (Biostatistics)

Location: Washington, D.C., United States

Company

hirify.global is a biotechnology company developing medicines across oncology, inflammation, general medicine, rare disease, and obesity-related conditions.

What you will do

• Advise therapeutic-area and product leaders on development strategies, clinical study designs, and statistical approaches.
• Evaluate conventional and innovative trial designs, estimands, estimators, regulatory considerations, operational feasibility, and development objectives.
• Direct, interpret, and communicate modeling and simulation activities with quantitative partner teams.
• Review development plans, Phase 2 and Phase 3 protocols, study design proposals, and key design elements.
• Provide senior methodological advice on complex development decisions, regulatory interactions, filings, and reimbursement submissions.
• Advance innovative design and analysis methods across products and programs while building partnerships with cross-functional and governance stakeholders.

Requirements

• Doctorate plus 5 years, master's degree plus 9 years, or bachelor's degree plus 11 years in Statistics, Biostatistics, or a related field with high statistical content.
• At least 12 years of post-graduate statistical experience in the biopharmaceutical industry across clinical trial design, execution, analysis, and reporting.
• At least 5 years of direct people management or leadership experience directing teams, projects, programs, or resource allocation.
• Expertise in statistical methods and leadership across drug development phases, regulatory submissions, and payer interactions.
• Strategic statistical leadership at the product level and experience advising large, complex development programs.
• Strong scientific communication, problem-solving, influencing, negotiation, business acumen, and strategic thinking skills.

Nice to have

• Doctorate in Statistics or Biostatistics and pharmaceutical or medical research experience.
• Experience with conventional and innovative trial designs, advanced statistical analysis, modeling, and simulation.
• Knowledge of disease areas and regulatory guidelines, including regulatory or reimbursement submissions.
• Scientific publications, external industry or academic visibility, and recognized statistical leadership.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions, stock-based long-term incentives, and an annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are anticipated to be accepted until August 31, with possible extension if additional candidates are needed.
• Sponsorship for the role is not guaranteed.