Statistical Programming-Biometrics Manager
Description OPKO Renal, LLC is a division of OPKO Health, Inc., a publically traded healthcare company involved in the discovery, development, and commercialization of proprietary pharmaceutical products, medical devices, vaccines, and diagnostic technologies.
The Statistical Programming – Biometrics Manager is responsible for managing projects and junior Programmers while also developing and implementing SAS programs to produce descriptive and statistical analyses.
Duties and Responsibilities
- Leads and oversees all programming support activities for a clinical program in line with acceptable statistical methodology, timely and accurate data integration, analysis data standards submissions (data tabulation models).
- Develops and implements new statistical programming methods and technologies for reporting and managing clinical data ensuring consistency in infrastructure within Statistical computing organization
- Actively participates in development of appropriate data collection instruments and database design requirements
- Provide effective input to Data Management activities and partnership with Statistical programming leadership and team to ensure the provision of high-quality data and outputs
- Retain and recruit talent, coach and develop reports
- Involved in the preparation and review of programming deliverables and resources for clinical study reports and scientific presentations; participate in team review of documents.
- Develops Statistical Analysis Plans, dataset/output specifications, and reviews protocols, modeling simulation plans, case report forms (CRF), guidelines and data description documents
- Determines documentation and archival standards of statistical programming deliverables including analysis databases, summaries, programs, and specifications.
- Supports achievement of major reporting deliverables and milestones for regulatory submissions
- Performs project management for programming deliverables in a project
- Develops Statistical Programming & Analysis related SOPs and contributes to developing Biometrics SOPs
- Develops statistical programming guidelines and training curriculum
- Builds effective partnerships with cross functional groups within Biometrics, and the study team to ensure that customer/stakeholder needs are met
- Ensures work adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions in all areas of execution
- Oversees CRO activities and reviews CRO deliverables as necessary
We offer competitive compensation and an excellent benefits package that includes:
- Master’s Degree in Computer Science, Statistics, Life Sciences or other relevant scientific subject with 4+ years of relevant experience or BS degree with 6 years of experience in pharmaceutical or biotechnology industry
- Bio statistical programming using the SAS system. Strong work ethics and experience with SAS/Base, SAS/STAT, SAS/Macro, SAS/SQL and SAS/GRAPH
- Extensive experience in the statistical analysis of biomedical data using statistical software such as SAS, SPSS, R and in the following areas of statistical programming: accessing data, creating data structures, managing data, and generating analysis reports
- Expert-level CDISC, SDTM & ADaM programming skills
- Advanced knowledge of regulatory guidelines and the software development life cycle
- Possess effective project planning and process improvement skills
- Experience in the management of people and projects
- Excellent verbal, written, communication and interpersonal skills
- Understanding of forecasting and budgeting processes
- Interact effectively with the clinical R&D team and regulatory as needed
- Ability to work independently while requiring limited detailed direction
- Must be capable of attending study team meetings as the primary statistical programming contact
- Less than 5% travel
401(k) Plan with Company Match
Paid Time Off
Excellent Medical and Dental Plans
Paid Life Insurance
Paid Disability Insurance
- Ability to work in the US without sponsorship is required