Statistical Programming Manager

About Us: 

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Job Title: Manager/Sr Manager of Statistical Programming        

Location: Remote or Hybrid if commutable to office in Waltham, MA employee will be required to be in-office 3 days/week.          

Role Overview:

Oruka Therapeutics is seeking an experienced Manager/Sr Manager of Statistical Programming to lead programming efforts across multiple clinical studies. This role will be instrumental in ensuring high-quality, timely, and compliant statistical deliverables in support of Oruka Therapeutics clinical trials. The ideal candidate will bring deep technical expertise in SAS programming, CDISC standards, and regulatory submission readiness, along with strong leadership and vendor oversight capabilities.

Key Responsibilities: 

• Lead statistical programming activities for multiple clinical trials within a program or a complete development program
• Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results
• Serve as the lead programmer to produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses; write specifications for programming requirements
•  Oversee CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality
• Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams