Senior Statistical Programmer (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: 

• Oversees development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers and checklists.
• Responsible for providing QC oversight of CRO deliverables like ADaMs, and tables, listings and figures.
• Independently develop SAS or other programs and specifications for production of output to support study needs including publications, safety reporting, ad hoc analyses in a timely fashion.
• Independently verify other programmers’ results.
• Develop and/or validate standard macros to automate output production.
• Adhere to company SOPs and department guidelines.
• Work concurrently on multiple projects.
• Troubleshoot technical and project issues.
• Help with infrastructure development of the department.
• Communicate effectively with internal cross-functional groups and external partners.

 Qualifications: 

• BS/BA degree in related discipline.
• At least 5 years of experience in statistical programming with clinical data and SAS.
• Experience in oncology therapeutic area strongly preferred.
• Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros.
• CDISC proficiency required.
• SAS/GRAPH experience desirable.
• 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.