Omeros Corporation Seattle, WA, USA
Mar 21, 2019Full time
Omeros is seeking a Head of Biostatistics, Data Management and Programming to join the Clinical Development Team. As a member of our team, you'll oversee the data management, programming and statistical team and will directly report to the CMO of Omeros. In this leadership role, the Head of Biostatistics, Data Management and Programming will be responsible for all bio-statistical and data management aspects of Preclinical and Clinical Research. The role will provide statistical expertise to multi-disciplinary project and study teams for the design of clinical development and/or life cycle management programs and studies for assigned projects to ensure that scientifically valid conclusions are drawn concerning claims with respect to efficacy and safety of the development candidate. 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? Contribute to the development and maintenance of methods and procedures based on Regulatory Guidelines and Company requirements Participate in Clinical Project and Study Team meetings Responsible within the Clinical Team for the quality, accuracy and timely completion of assigned statistical and data management tasks Responsible for making statistic model selection, experimental design, design and analysis of clinical trials and generation of the Statistical Analysis Plan Analyze and interpret data from individual trials Perform meta-analyses by pooling data from several studies Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format Co-operate in further development of internal guidelines and SOPs Prepare project summaries for regular status meetings and interact with Regulatory Statisticians Update knowledge in statistical concepts, methods, and techniques Maintain state of the art statistical applications in clinical research Lead corrective action plans and troubleshoot as necessary Advise on appropriate data collection tools and database design Maintain a proactive and forward-thinking approach to data management and report generation Supervise a capable, self-motivated team of programmers and data managers. including but not limited to overseeing and developing specific systems and team guidelines Set priorities in alignment with the clinical team and the CMO and assign resources for the Management of requests regarding data reporting, and analysis Partner with investigators and collaborators to achieve study and research objectives Master's degree or higher in Biostatistics, Epidemiology or related field and 8 - 12 years of related experience (dependent on degree) or equivalent combination of education and experience. As our ideal candidate, you'll need the following skills and knowledge: Proficient independent biostatistical consulting expertise Proficient in ERP System Proficient in either SAS or R statistical programming Proven supervisory and/or leadership skills Excellent analytical thinking skills Excellent written and verbal communication skills The employee is occasionally required to travel overnight Will need the ability to travel 20% of the time May encounter prolonged periods of sitting Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs 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. 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 or contact Omeros, asking for Human Resources, at .