Senior Manager, Biostatistics (Contract)

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

Key Responsibilities: 

• Works with project team members and manages CROs to generate clinical protocol, authors statistical analysis plan/TLF templates, analysis specifications, CRFs, and CRF edit checks.
• Performs analysis, interpret study results, and collaborates with clinical team to conduct interim data review, final reports and publications.
• Effectively manages CRO to ensure high-quality deliverables within timeline and budget.
• Responsible for more than one study with concurrent tasks and timelines.
• Participates in the validation/QC of key efficacy endpoints analyses and submission deliverables.
• Supports ongoing publication tasks to ensure smooth communication of output among cross-functional groups.
• Applies appropriate regulatory guideline to the projects.
• Adhere to company SOPs and department guidelines.
• Assists department head in department initiatives and process development.

Qualifications: 

• MS/MA degree in related discipline and a minimum of 5 years of experience; or PhD in related discipline with 3 years of experience; or equivalent combination of education and experience.
• Experience in oncology required.
• Experience in hematology-oncology and biomarkers preferred.
• Experience with overseeing CROs in the conduct of clinical trials.
• Experience with statistical applications and clinical data management in the conduct of clinical trials.
• Experience with development/review of SDTM/ADaM specifications.
• Strong SAS programming knowledge required.
• Knowledge of Cytel East package and R programming preferred.
• Knowledge of appropriate regulations, industry standards and guidance documents.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners.

Competencies:

• Has character and integrity. Committed to always doing what’s right.
• Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
• "No job is too small" mentality. Humble and willing to help others.
• Able to build strong relationships and collaborate effectively with colleagues.
• Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
• Always looking to improve and challenge the status quo. Gritty and determined.