Senior Director, Statistical Programming at Arcellx

Redwood City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

BS/BA degree in related discipline
13+ years of experience in statistical programming with clinical data and SAS
Experience in oncology therapeutic area preferred
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
CDISC expertise required
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
Excellent interpersonal communication skills

Responsibilities

Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs
Review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH
Oversee and manage work of other programmers
Develop and/or validate standard macros to automate output production
Assist with infrastructure development of the department

Skills

SDTM

ADaM

CDISC

Statistical Programming

annotated CRFs

XML

CRO Oversight

Arcellx

Develops immunotherapies for cell therapy

About Arcellx

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the effectiveness of treatments. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Gaithersburg, MarylandHeadquarters

2014Year Founded

$194.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Flexible Work Hours

401(k) Company Match

Fully-Paid Parental Leave

Tuition Reimbursement

Relocation Assistance

Risks

Competition from established CAR-T therapies like Abecma and Carvykti could limit market share.

Dependency on Gilead's Kite partnership poses risks if partnership dynamics change.

Phase 3 iMMagine-3 trial delays or failures could impact anito-cel's market timeline.

Differentiation

Arcellx's CART-ddBCMA has FDA Fast Track and Orphan Drug designations.

The novel D-Domain binder in anito-cel enhances antigen binding and cell killing.

ARC-SparX offers dosable and controllable CAR-T therapy options.

Upsides

Growing investment in personalized medicine aligns with Arcellx's tailored immunotherapies.

Advancements in gene editing like CRISPR enhance precision in engineered cell therapies.

Outpatient CAR-T administration could reduce costs and increase accessibility for Arcellx.

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