Senior Statistical Programmer

About this role

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 A Senior Statistical Programming is an expert in the management, technical oversight, and quality of 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 as well as mentor and train junior staff members as applicable.

Essential Functions • Lead all aspects of statistical programming activities inclusive of creation, validation, traceability, reproducibility, and maintenance of analysis datasets and statistical outputs. • Contribute to and review statistical analysis plans and analysis datasets specifications. • Prepare the electronic submission of clinical trial data to regulatory authorities. • Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project. • 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 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 development of new processes or revision of existing processes. • Keep current with new statistical programming techniques and technical advancements. • As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. • Train junior staff in more complex statistical programming techniques. • Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. • Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.

Education & Experience • Bachelor’s Degree in Statistics/Biostatistics, Computer Science, Mathematics, or other field of study with at least 7+ years of relevant experience is required; OR • Master’s Degree in Statistics/Biostatistics, Computer Science, or Mathematics, or other field of study with at least 5+ years of relevant experience is required. • 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred.

Knowledge, Skills, & Abilities • Demonstrated knowledge and ability in efficient programming techniques • 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.

Working Environment / Physical Environment • This position work onsite in our Dunkirk, NY location or remotely depending on the candidate’s geographic location. • 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.   National Market (all markets unless identified as Premium) $135,000 (entry-level qualifications) to $150,000 (highly experienced) annually   Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $144,000 (entry-level qualifications) to $160,000 (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 candid

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