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    Director, Biostatistics - San Carlos, United States - Cargo Therapeutics

    Cargo Therapeutics
    Cargo Therapeutics San Carlos, United States

    4 weeks ago

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    Description

    Job Description

    Job DescriptionThe Director, Biostatistics will be responsible for partnering with scientists in Clinical, Safety, Translational Medicine, Regulatory, and Product Development on clinical development projects, development science applications, and/or process/product manufacturing applications, and is accountable for the statistical integrity, adequacy, and accuracy of these assignments. The role is based in San Carlos, CA. WHAT YOU'LL DO AT CARGO THERAPEUTICS Essential duties and responsibilities include the following; other duties may also be assigned:
    • Work as lead biostatistician to provide analytical leadership on study planning, conduct, analysis, result interpretation, and reporting for assigned projects
    • Partner with other functions to write, review, and execute protocols and various analysis plans
    • Analyze data and interpret results from clinical trials to meet the project objectives; may work on exploratory analyses related to clinical pharmacokinetic/pharmacodynamic, translational biomarker, and/or manufacturing data
    • Apply and implement basic and complex statistical techniques independently to assigned projects
    • Assist in the oversight of data flow and transfers to ensure timing and quality of data collection as well as data reporting
    • Work with Statistical Programming to ensure programs meet analysis requirements, internal SOPs, and external regulatory requirements
    • Oversee the activities of statistical service providers, as appropriate
    • Keep abreast of new developments in statistics, drug development, and regulatory guidance
    THE RIGHT STUFF: Required Experience & Qualifications
    • PhD in Statistics, Biostatistics, or Mathematics with at least 7 years in the clinical development setting in pharmaceutical or biotechnology industry, or Master's degree in related discipline with a minimum of 12 years' relevant experience
    • Experience in CAR T-cell therapy not mandated
    • Good knowledge and experience applying statistical methods to drug development
    • Able to take dynamically assigned pharmacometrics tasks and deliver the results in a timely manner
    • Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences
    • Driven for results with demonstrated interest and ability to welcome new challenges, embrace changes, take initiative, and find solutions to technical problems
    • Proficient in SAS and R
    PAY RANGE The combined pay range for this role is $195,000 - $270,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. ABOUT CARGO THERAPEUTICS CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo- Join us to help make a difference EEO & EMPLOYMENT ELIGIBILITY CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law. CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
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