What At Lumicell: We’ll give you the opportunity to harness all that’s within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer due to cancer being left behind during surgery. You will be a part of something groundbreaking as we transition from clinical development to our commercial launch. Senior Biostatistician Lumicell is hiring a Senior Biostatistician to lead the biostatistics efforts in the clinical development of multiple portfolio indications including feasibility, pivotal, and post-market studies. What you will do: Design and develop statistical methodologies for clinical trials including authoring statistical analysis plans (SAPs) to support pre- and post-market clinical study protocols, estimation power and sample size, and determination of hypothesis tests and success criteria and data to be collected to support study endpoints. Ensure data and results accuracy and integrity following quality assurance procedures. Maintain and be responsible for SAS programs and statistical documents in each study’s Trial Master File. Contribute to clinical protocol development, including study designs with novel and efficient biostatistical techniques that support study objectives and timelines. Review and provide feedback to clinical study documents, including study protocols, Case Report Forms, database specification documents, and related material by working closely with Clinical Affairs and Data Management. Analyze and present clinical trial data using advanced statistical techniques. Support clinical trial execution by developing and executing data cleaning programs. Responsible for designing, programming and generating study-related tables, listings, and figures (TLF), hardcoding plans and reports, and contribute to the preparation of Clinical Study Reports (CSRs), Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and Summary of Safety and Efficacy Data (SSED). Lead efforts for maintaining compliance with data results postings to ClinicalTrials.gov. Participate in the preparation of regulatory submissions and regulatory meetings, and address statistical questions from regulatory agencies. Collaborate and provide programming and statistical support to internal and external (clinical investigators) for study-related peer-review publications, abstracts, and conference presentations. Respond to data requests from multiple internal departments to support internal and external data presentations. Support grant writing efforts by providing data analysis plans and expected results, and identifying study challenges and mitigation strategies. What you will bring: PhD. degree in biostatistics, mathematics or related fields preferred. 8+ years of biostatistics and FDA-regulated clinical data experience strongly desired. Strong verbal and written communication, presentation, analytical, and problem-solving skills. Proficiency in statistical analysis packages (e.g., R, SAS, IDL) and programming languages (e.g. Python, Ruby, Java, Julia). Familiarity with ICH Good Clinical Practice (GCP) guidelines (ICH E9 and ICH E6). Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #J-18808-Ljbffr Lumicell Inc.
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