Principal Biostatistician

🕒 June 24

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ImmunityBio, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

ImmunityBio, Inc. is a biotechnology company focused on developing innovative immunotherapies to enhance the immune system's ability to fight cancer and infectious diseases. By harnessing the power of the body’s immune response, ImmunityBio aims to provide breakthrough treatments that can improve patient outcomes and longevity in challenging diseases.

📋 Description

• 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.

🎯 Requirements

• 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. • 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. • Excellent analytical skills with meticulous attention to detail. • Excellent English verbal and written communication skills; good organizational and interpersonal skills.

🏖️ 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 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