Associate Director, Statistical Programming - Cargo Therapeutics
San Carlos, CA
About the Job
CARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time, and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences.
We are actively seeking an exceptionally motivated individual to fill the role of Associate Director in our Statistical Programming team. In this pivotal role, you will report directly to the Head of Statistical Programming and play a critical role in advancing our Clinical Development programs. Your responsibilities will encompass a wide range of Statistical Programming tasks and contribute towards maintaining a robust analytical programming environment. This role demands a dynamic combination of analytical acumen, technical proficiency, and a deep commitment to driving the success of our Clinical Research initiatives.
The role is based in San Carlos, CA.
WHAT YOU’LL DO AT CARGO THERAPEUTICS
Responsibilities of the Associate Director, Statistical Programming include but are not limited to:
- Provide hands-on statistical programming support for Clinical Study Reports (CSRs), scientific publications, presentations, Investigator's Brochures (IB)/Development Safety Update Reports (DSUR), interim Data Monitoring Committees (iDMC), clinical data reviews, and ad-hoc analyses
- Develop CDISC compliant and robust ADaM datasets specifications; develop and validate tables, listings, and figures (TLFs)
- Ensure quality of deliverables by consistently applying analysis and reporting standards and driving compliance with regulatory requirements, corporate, and departmental SOPs, and work practices
- Create and maintain auditable study documentation
- Provide vendor oversight of CDISC SDTM datasets and PK/PD analyses ensuring quality and compliance
- Collaborate with the study statistician and other team members for effective project planning and timeline management
- Collaborate with IT and external vendor(s) to maintain a secure, robust, and efficient statistical programming environment
THE RIGHT STUFF: Required Experience & Qualifications
- Bachelor’s degree in Computer Science, Statistics, Life Sciences, or a related field is required; Master’s degree preferred
- Minimum of 8 years of experience in statistical programming within the pharmaceutical/biotech industry
- At least 5 years of statistical programming experience in the Oncology therapeutic area
- Experience with BLA or NDA/sNDA submissions
- Strong SAS programming experience with SAS Base, SAS/Stat, SAS/Graph; infrastructure programming experience a plus
- Strong hands-on programming skills to deliver results in a fast-moving and evolving environment
- Thorough understanding of clinical trial design and reporting processes, and regulatory reporting requirements including electronic data submissions, and CDISC implementation
- Excellent verbal and written communication skills; organizational skills; able to communicate proactively and effectively
PAY RANGE
The combined pay range for this role is $165,000 - $225,000. 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-tx.com/.
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.
Source : Cargo Therapeutics