Principal Biostatistician

Company Overview
ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Why ImmunityBio?

* ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.

* Work with a collaborative team with the ability to work across different areas of the company.

* Ability to join a growing company with professional development opportunities.

Position Summary

The Principal Biostatistician will be the subject matter expert in design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met. This position leads statistical strategy and provides expert guidance across our clinical development programs. In this role, you will serve as the primary statistical lead for complex studies and collaborate cross-functionally to ensure rigorous, innovative, and regulatory-compliant statistical practices.

Essential Functions

• Serve as the lead statistician for one or more clinical programs, overseeing all statistical aspects from study design through regulatory submission.
• Lead the design of all clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• Lead the development of clinical trial protocols and clinical study reports; write statistical methodology section of these documents.
• Develop and review statistical analysis plans (SAPs), including methodology, sample size calculations, and interim analysis strategies
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Lead the electronic submission of clinical trial data to regulatory authorities.
• Partner with clinical, regulatory, data management, and medical affairs teams to align statistical approaches with program objectives.
• Proactively solve problems of statistical complexity.
• 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).
• Communicate complex statistical concepts clearly to non-statistical stakeholders, including senior leadership and external collaborators.
• Participate effectively as a key member on clinical study teams.
• Provides analytical insight on statistical methodology and advice to internal teams of accordingly.
• Keep current with new clinical trial designs and statistical methodology.
• As necessary, provide work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more complex statistical methodology.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor's Degree in Statistics or Biostatistics is required with at least 10+ years of relevant experience is required; OR
• Masters's Degree in Statistics or Biostatistics is required with at least 8+ years of relevant experience is required.
• 5+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required.
• Experience as a Lead Biostatistician on several concurrent projects required.
• Experience with CDISC STDM/ADaM required.

Knowledge, Skills, & Abilities

• Working knowledge of clinical research, Good Clinical Practices (GcP), and regulatory requirements/guidelines.
• Knowledge of adaptive trial designs, Bayesian methods, or complex innovative designs
• Proficient in SAS; familiar with sample size software such as nQuery or PASS.
• Ability to align statistical approaches with broader business and regulatory goals.
• Ability to influence decisions and mentor others
• Excellent analytical skills with meticulous attention to detail.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Working Environment / Physical Environment

• This position work onsite in Dunkirk, NY
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$175,000 (entry-level qualifications) to $195,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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 are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.