Senior Statistical Programmer

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Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. 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, 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 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 loca