Senior Manager, Statistical Programming (Remote)

Oruka Therapeutics; Waltham (MA); Hybrid; USD 146,000 - 187,000; Full time

Benefits offered by this job

Equity

Bonus opportunity

Remote work

Office in Waltham

Job summary

Oruka Therapeutics is seeking a Manager/Sr Manager of Statistical Programming to lead programming across multiple clinical studies in a remote/hybrid setup near Waltham, MA. The role focuses on high-quality, timely deliverables and regulatory submission readiness, with strong SAS/CDISC expertise and vendor oversight.

You will collaborate with Biostatistics and Data Management, oversee CROs, and drive tools to enhance efficiency while ensuring FDA/EMA/ICH guideline compliance.

Qualifications

• BS/MS in life science, CS, stats, or equivalent with 5+ years in programming/stats.
• 2+ years as Lead/Program/Project Programmer coordinating large teams.
• Experience with CDISC standards and regulatory submissions.
• Strong leadership, collaboration and multi-trial management skills.
• Knowledge of FDA/EMA/ICH guidelines for trials and data handling.
• Experience with CRO oversight and outsourcing.

Responsibilities

• Lead programming for multiple clinical trials; ensure quality and timeliness.
• Validate tables, listings, figures and datasets for regulatory needs.
• Oversee CRO SAS programming and maintain project timelines.
• Collaborate with Biostatistics and Data Management to ensure data integrity.
• Develop global tools to improve efficiency of the programming group.
• Maintain up-to-date SAS knowledge and regulatory standards.

Skills

Leadership

SAS programming

CDISC standards

Regulatory submission

Vendor oversight

Communication

Education

BS/MS in life science, CS, stats or related

Tools

SAS

R

Job description

Oruka Therapeutics is seeking a Manager/Sr Manager of Statistical Programming to lead programming across multiple clinical studies in a remote/hybrid setup near Waltham, MA. The role focuses on high-quality, timely deliverables and regulatory submission readiness, with strong SAS/CDISC expertise and vendor oversight.

You will collaborate with Biostatistics and Data Management, oversee CROs, and drive tools to enhance efficiency while ensuring FDA/EMA/ICH guideline compliance.