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ImmunityBio, Inc. logo
ImmunityBio, Inc.

Outsmart Your Disease™

Senior Biostatistician

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 501-1,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

88 days ago

Salary

$144K - $180K / year

Seniority

Senior

Bachelor Degree7 yrs expEnglishGCP

Job Description

Senior Biostatistician

ImmunityBio, Inc.

• 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 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 the 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. • 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 as assigned to support business needs and provide developmental opportunities.

Job Requirements

  • Bachelors’ Degree in Statistics or Biostatistics is required with at least 7+ years of relevant experience is required; OR Masters’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience is required.
  • 3+ years of experience Biostatistician in the Biotech or Pharmaceutical industry is required.
  • 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.

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

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