Manager/Senior Manager of Statistical Programming at Oruka Therapeutics in Waltham, MA

Job description

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 Collaborate with biostatisticians and clinical development colleagues to develop/review TFL shells, SDTM, and ADaM specifications Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the statistical programming group Maintain up-to-date advanced knowledge of SAS software as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training Represent statistical programming at program-level, in audits/inspections and Health Authority (HA) meetings Offer expert technical and professional recommendations, thought leadership for the statistical programming function at the program level Adhere to FDA regulations regarding training records, guidelines, and SOPs. Adhere to company SOPs/WIs and department guidelines Qualifications: BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 5+ years in a programming or statistical role At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs, including the coordination of large teams of internal and/or external programmers Demonstrated leadership, collaboration, and organizational s