Senior Statistical Programmer (Fully Remote or Hybrid)

Company: ImmunityBio, Inc.
Location: Cary
Posted on: August 7, 2022

Job Description:

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." 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.ImmunityBio, Inc. is looking for a Senior Statistical ProgrammerFully RemoteWho we are:ImmunityBio, Inc. is a clinical-stage biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company's range of immunotherapy and cell therapy platforms that collectively act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. 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. What you'll be doingA Senior Statistical Programmer is experienced in statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. They contribute to process improvements and initiatives within the Biometrics department.You will be responsible for...Lead aspects of the statistical programming activities, including:Efficient programming techniques.Creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.Contribution to and review of statistical analysis plans and analysis datasets specifications.Prepare the electronic submission of clinical trial data to regulatory authorities.Provide effective solutions for complex statistical programming tasks.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).Create and manage the project and study electronic subdirectories ensuring consistency in structure.Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.Participate in the development of new processes or revision of existing processes.Keep current with new statistical programming techniques and technological advancements.As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex statistical programming techniques.What skills & experience you'll bring to usBachelor's Degree in Statistics/Biostatistics, Computer Science, or Mathematics.5-7 years of experience as a statistical programmer in the pharmaceutical industry.Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.Technically strong with regard to statistical programming processes and activities.Highly proficient in SAS.Experience as a lead statistical programmer on several concurrent projects.Understanding of CDISC STDM/ADaM guidelines.Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Keywords: ImmunityBio, Inc., Cary , Senior Statistical Programmer (Fully Remote or Hybrid), IT / Software / Systems , Cary, North Carolina