Associate Director, Statistical Programming

Summary

Join Orca Bio, a late-stage biotechnology company focused on developing next-generation cell therapies for blood cancer, as an Associate Director of Statistical Programming. This role involves leading a team of statistical programmers to deliver high-quality programming support for clinical trials and regulatory submissions. You will oversee programming activities, ensure compliance with industry standards, collaborate with cross-functional teams, and drive process improvements. The ideal candidate will have a Master's degree in a relevant field, 10+ years of statistical programming experience in the pharmaceutical or biotech industry, and 4+ years in a leadership role. Orca Bio offers a competitive salary, pre-IPO equity, comprehensive benefits, and a dynamic work environment.

Requirements

• Master’s degree or above in Statistics, Computer Science, Life Sciences, or a related field
• 10+ years of statistical programming experience in the pharmaceutical or biotech industry
• 4+ years in a leadership or supervisory role
• Proven track record in supporting clinical trials (Phase I-IV) and regulatory submissions
• Expertise in SAS programming (Base, Macro, SQL); familiarity with R or Python is a plus
• In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements
• Experience with data visualization tools and clinical data management systems
• Strong leadership and team-building capabilities
• Excellent communication and interpersonal skills for cross-functional collaboration
• Problem-solving mindset with attention to detail and accuracy

Responsibilities

• Oversee a team of statistical programmers, providing mentorship, performance management, and career development
• Allocate resources effectively to meet project demands
• Ensure development, validation, and maintenance of statistical analysis datasets, tables, listings, and figures (TLFs) per study protocols and statistical analysis plans
• Guarantee programming deliverables comply with industry standards (e.g., CDISC, SDTM, ADaM) and regulatory guidelines (FDA, EMA, etc.)
• Partner with biostatistics, data management, clinical operations, and regulatory affairs teams to align programming activities with study objectives
• Drive the development and implementation of programming standards, templates, and automation tools to enhance efficiency and quality
• Manage timelines, budgets, and deliverables for multiple projects, ensuring milestones are met within scope
• Coordinate with external vendors or contract research organizations (CROs) as needed to ensure consistency and quality of outsourced programming work
• Stay updated on industry trends, emerging technologies, and best practices to integrate innovative solutions into programming workflows

Preferred Qualifications

Experience with oncology, cell therapy, and/or complex therapeutic areas

Benefits

• Pre-IPO equity
• Medical, dental, and vision benefits
• Flexible PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Free daily lunches and snacks at our on-site locations