Principal Statistical Programmer
The Principal Statistical Programmer, Biometrics defines and leads group activities that support research and development studies. This role contributes to both pre-clinical and clinical studies, and requires expert team leadership of Statistical Programming responsibilities such as: exploratory analyses; clinical data programming; data assessment and acceptance checks; statistical programming for the production of high-quality deliverables that support internal decision-making, clinical study reports, regulatory agency reports and NDAs, submission documents, and publications and manuscripts.
This position reports to the Director, Statistical Programming. The Principal Statistical Programmer leads organizational and infrastructure improvement initiatives as well as project activities, which include planning, specifying, designing, developing, implementing, and disseminating statistical software solutions according to applicable study, project, corporate, and industry guidelines.
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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 internal decision-making and for submission to regulatory agencies
- Lead 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
- Lead the creation and development of specifications for tabulation and analysis databases (e.g., SDTM and ADaM)
- Lead the creation of submission package materials such as DEFINE files and Reviewer's Guides
- Represent the Statistical Programming group and the Biometrics Department to clinical teams and coordinate statistical programming input for research and development activities such as document and specification review, workflow management and quality specification
- Coordinate group activities and timelines with cross-functional colleagues
- Ensure the completion and successful validation of deliverables according to company SOPs, regulatory guidelines and ICH guidelines as needed to ensure appropriate accuracy, quality, and reproducibility
- Demonstrate leadership in the design and 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:
- Master's degree in Computer Science with emphasis in Statistics, Biostatistics, or Public Health with a Biostatistics/Epidemiology focus, or a related scientific discipline
- Technical expertise including a minimum of 8 years 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
- Expert programmer, able to develop applications and verify deliverables with little or no supervision using SAS
- Expert team leadership, including time and resources estimation, progress tracking and status reporting
- Demonstrated ability to deliver high-quality results on time
- Specific industry expertise including
- Defining and preparing CDISC data structures, domains and metadata
- Applying biostatistics to clinical data in biopharmaceutical research
- Defining, tracking, and confirming quality assurance practices
- Producing publication-ready tables, graphs, and listings for clinical study reports, regulatory agencies, scientific journals, and conferences
- Strong analytical and problem-solving skills
- Demonstrated detail orientation
Behavioral Competencies Required:
- Ability to build and maintain positive relationships with management, peers, and subordinates
- Excellent interpersonal, and verbal and written communication skills
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