Statistical Programming-Biometrics Manager
OPKO Health - Miami, FL

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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
Qualifications
  • 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
We offer competitive compensation and an excellent benefits package that includes:

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

OPKO Health - 6 months ago - save job - block