Statistical Programmer/Sr. Statistical Programmer
The Statistical Programmer/Sr. Statistical Programmer will support research and development studies. This role contributes to both pre-clinical and clinical studies, and requires clinical data programming experience such as edit checks, and statistical programming experience for producing reports and data displays such as tables, listings and graphs to support clinical study reports, regulatory agency reports and NDAs, and submission high level documents and publications.
This position reports to the Director, Statistical Programming. The Statistical Programmer/Sr. Statistical Programmer focuses on leading study and project activities, including planning, specifying, designing, developing, implementing, and disseminating statistical software solutions according to applicable study, project, corporate, and industry guidelines.
Good things are happening at Omeros!
Come join our Omeros Clinical Team!
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.
What are your job responsibilities?
- Configure software and write programs that produce deliverables such as data sets, tables, listings, and graphs to support research and development projects, including materials for submission to regulatory agencies
- Effectively manage study and project workload, including prioritization to meet company objectives, estimation of resources required to meet timelines, securing team resources, defining quality and completion criteria, and tracking team progress to completion
- Coordinate activities and timelines with team members and customers
- Represent the Statistical Programming group and the Biometrics department to clinical teams and coordinate statistical programming input for development activities such as document review, workflow management and quality specification
- Complete deliverables according to guidelines, specifications and requirements for content, accuracy, quality, and reproducibility
- Demonstrate leadership in the continual improvement of statistical programming best practices, Work Instructions and Standard Operating Procedures (SOPs) as needed to ensure that they meet ICH and regulatory requirements
- Perform ad hoc analyses and data validation using pharmaceutical industry knowledge, experience, and advance statistical analytics
Education, Experience, Skills, and Knowledge Required:
- BS degree in Computer Science or related technical discipline with minimum of 2 - 5 years, for a Statistical Programmer, and 5 ‑ 8 years, for a Sr. Statistical Programmer, of SAS and SQL experience in a pharmaceutical, biotech, CRO setting, or other clinical development organization; experience with additional programming languages such as R or python is a plus
- Good understanding of and hands-on experience with CDISC, SDTM, and ADaM standards
- Experienced programmer, able to develop applications and verify deliverables with little or no supervision using SAS
- Experienced team leadership, including time and resources estimation, progress tracking and status reporting
- Experienced in program edit checks, creating and reviewing SAS data structures, and uploading data transfers to and from contracted studies with CROs and/or other vendors
- Demonstrated ability to deliver high-quality results on time
- Demonstrated display of strong analytical and problem-solving skills; excellent attention to detail in preparing deliverables and communications
- Excellent interpersonal, verbal and written communication skills
- Proficiency in Microsoft Office; Word, Excel, PowerPoint, and Outlook
Behavioral Competencies Required:
- Ability to build and maintain positive relationships with management, peers, and subordinates
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 10 lbs.
- May encounter prolonged periods of sitting
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000