Biostatistician - fully remote

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION:

The Biostatistician has an understanding of the design, management, technical oversight, and quality of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met. While the company has offices in Cary, NC this hire will be able to work remotely from anywhere in the country, and travel will be limited to occasional office visits when it's considered safe to do so.

ESSENTIAL FUNCTIONS:

• Lead aspects of the statistical analysis including:

  • Contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.

  • Contribute to the development of clinical trial protocols and clinical study reports; write the statistical methodology section of these documents.

  • Prepare statistical analysis plans, statistical output shells, and analysis dataset specifications.

  • 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 SDTM/ADaM, and e-submissions).

• Participate effectively as a key member of clinical study teams.

• Provides analytical insight on statistical methodology and advice to internal teams 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.

QUALIFICATIONS:

• Bachelor's Degree (Master’s Preferred) in Statistics or Biostatistics

• 2-4 years of experience as a Biostatistician in the Biotech or Pharmaceutical industry, oncology experience preferred

• CDISC STDM/ADaM experience

• Excellent English verbal and written communication skills; good organizational and interpersonal skills

• Working knowledge of clinical research, Good Clinical Practices, 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 is preferred.

• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Want to apply? Get in touch today

Visit us at www.ImmunityBio.com/careers to view any of our current openings and apply today!

Disclaimer

ImmunityBio, Inc. is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.