Senior Biostatistician
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products designed to strengthen each patient’s natural immune system, enabling it to outsmart disease and eliminate cancerous or infected cells. Our vision is a future where cancer is no longer feared but conquered through the power of the human immune system. We are developing novel therapies that amplify both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow—reprogramming the patient’s immune system to treat the host rather than just the disease.
About the Role
The Senior Biostatistician will serve as the subject matter expert in the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data, ensuring timelines and company strategic objectives are met.
Responsibilities
- Lead and contribute to the design of phase I-III clinical trials, including sample size calculations, interim analyses, DMC activities, and randomization procedures.
- Lead and contribute to the development of clinical trial protocols and clinical study reports; write the statistical methodology section of these documents.
- Develop and prepare statistical analysis plans, statistical output shells, and analysis dataset specifications.
- Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs.
- Contribute to the electronic submission of clinical trial data to regulatory authorities.
- Proactively solve problems of statistical complexity.
- Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
- Participate effectively as a key member on clinical study teams.
- Provide analytical insight on statistical methodology and advice to internal teams.
- Keep current with new clinical trial designs and statistical methodology.
- Provide work direction, guidance, mentoring, influence, and support to junior staff as necessary.
- Train junior staff in more complex statistical methodology.
- Create, edit, and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Perform ad-hoc and cross-functional duties and/or projects to support business needs and provide developmental opportunities.
Requirements
- Bachelor’s Degree in Statistics or Biostatistics with at least 7+ years of relevant experience; OR
- Master’s Degree in Statistics or Biostatistics with at least 5+ years of relevant experience.
- 3+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry.
Skills
- Working knowledge of clinical research, Good Clinical Practices (GcP), and regulatory requirements/guidelines.
- Proficient in SAS; familiar with sample size software such as nQuery or PASS.
- Experience as a Lead Biostatistician on several concurrent projects.
- CDISC STDM/ADaM experience.
- Excellent English verbal and written communication skills; good organizational and interpersonal skills.
Work Environment
This position may be onsite or remote, depending on the candidate’s geographic location. Regular work schedule is Monday – Friday, within standard business hours, with flexibility available upon manager approval. Must possess mobility to work in a standard office setting and use standard office equipment, including a computer. Ability to lift and carry materials weighing up to 20 pounds.
Pay
National Market (all markets unless identified as Premium): $144,000 (entry-level qualifications) to $160,000 (highly experienced) annually.
Premium Market (Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $162,000 (entry-level qualifications) to $180,000 (highly experienced) annually.
This position is eligible for a discretionary bonus and equity award.
Benefits
- Medical, Dental, and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance, and Employee Discounts, Rewards, and Perks
- Paid Time Off (PTO) includes:
- 11 Holidays
- Exempt Employees: Unlimited PTO
- Non-Exempt Employees: 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day