The Clinical Department is seeking a Statistical Programmer to 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 of Statistical Programming. The Statistical Programmer focuses on 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 Clinical Development Group!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
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 workload, including estimation of efforts and timelines, prioritization to meet company objectives, and tracking of progress to completion Coordinate activities and timelines with team members and customers Complete deliverables according to guidelines, specifications and requirements for content, accuracy, quality and reproducibility Contribute to the continual improvement of Statistical Programming best practices, Work Instructions and Standard Operating Procedures (SOPs) as needed to ensure that they meet ICH regulatory requirements BS degree in Computer Science or related technical discipline with 2-5 years of SAS experience in a pharmaceutical, biotech, CRO setting or other clinical development organization Experienced programmer, able to develop applications and verify deliverables with minimal supervision using SAS 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 Must have the ability to build and maintain positive relationships with management, peers, and subordinates Excellent written and verbal skills required Must display strong analytical and problem-solving skills Attention to detail required Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs. May encounter prolonged periods of sitting
If you have the skills, knowledge and experience we are looking for, we'd love to hear from you!
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.