Remote Senior Manager, Statistical Programming

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

Benefits offered by this job

Equity

Bonus potential

Remote/hybrid options

Professional growth

Job summary

Oruka Therapeutics in the United States is seeking a Manager/Sr Manager of Statistical Programming to lead programming across multiple clinical studies, ensuring high-quality, timely deliverables and regulatory submission readiness with SAS and CDISC expertise.

You will provide leadership, CRO oversight, and collaborate with Data Management and Biostatistics to ensure accurate databases, analyses, and reports while advancing standards and tools.

Qualifications

• Lead statistical programming activities for multiple clinical trials within a program or a complete development program.
• Audit readiness of all programming deliverables and reliability of analysis results.
• Produce/validate tables, listings, figures, and analysis datasets for regulatory requests and publications.
• Oversee CRO SAS programming and ensure timely, quality delivery.
• Collaborate with Data Management and Biostatistics to ensure accurate databases, analyses, and reports.
• Develop/review SDTM/ADaM specifications with biostatisticians.
• Identify opportunities to improve efficiency with global tools.
• Maintain up-to-date knowledge of SAS and industry standards; attend meetings.
• Represent statistical programming at program-level in audits/HA meetings.
• Provide recommendations and thought leadership; adhere to FDA regulations and SOPs.

Responsibilities

• Lead programming activities for multiple clinical trials within a program.
• Ensure timely and quality development of all statistical programming deliverables.
• Produce and validate tables, listings, figures, and analysis datasets for regulatory requests and publications.
• Oversee CRO SAS programming and ensure on-time, quality delivery.
• Collaborate with Data Management and Biostatistics to ensure accurate databases, analyses, and reports.
• Develop SDTM/ADaM specifications with biostatisticians.
• Identify opportunities to improve efficiency with global tools.

Job description

Oruka Therapeutics in the United States is seeking a Manager/Sr Manager of Statistical Programming to lead programming across multiple clinical studies, ensuring high-quality, timely deliverables and regulatory submission readiness with SAS and CDISC expertise.

You will provide leadership, CRO oversight, and collaborate with Data Management and Biostatistics to ensure accurate databases, analyses, and reports while advancing standards and tools.