Grifols Veterans Jobs

Job Information

Grifols Shared Services North America, Inc Statistical Programmer 3 in Durham, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Provides statistical programming support to all Grifols clinical trials and supervises the statistical programming activities performed internally and externally. Provides guidance to the clinical development department in the direction of clinical data standard, statistical tables, listing, and figures standards for the medical research report and for regulatory submissions.

Primary responsibilities:

  • Manages and coordinates the programming activities in clinical trials to ensure the timely completion and the quality of the analysis result presentation.

  • Lead the development and review of SDTM and ADAM data specifications

  • Generates and validates statistical analyses (tables, listings, and figures) using SAS and other software. Assists in the development of data analysis plan, coordinates programming and data management process with contractors/CROs, reviews the statistical deliverables, ensures the quality of the deliverables, and acts as an integral member of a clinical project team.

  • Interacts regularly with other team members within clinical development department or in other departments, preventing potential issues and/or reconciling if the issues occurred.

  • Maintains overall awareness in the field of statistical programming by self-training, attending training class/conferences. Maintaining current professional knowledge in broad range of clinical research.

  • Performs validation and quality review of deliverables provided by internal or external resources.

  • Supports the Regulatory Affairs with electronic submission to FDA by preparing the documents under CRT folder with compliance to eCTD guidelines.

  • Reviews the programming and data management related documents, e.g.. case report form(CRF) design, Annotation of CRF, edit checks, database structure.

Additional responsibilities:

Provides scientific consulting in programming and data analysis to other departments. Leads the development of new initiatives for technical enhancement and process improvement (e.g.. standard Table/Listing/Figure shells). Assists the Head of Biometry in budget and resource planning and forecasting.

Knowledge, skills, & abilities:

Advanced knowledge of medical and statistical terminology. Advanced programming skills in SAS, including SAS macro language, data manipulation techniques, data reporting procedures (PROC REPORT, ODS, SAS/Graph), and statistical procedures (e.g., PROC FREQ, PROC UNIVARIATE, PROC GLM, PROC MIXED). Strong organization, analytical, verbal and written communication skills. Ability to multitask and prioritize work. Ability to implement the regulatory standards in clinical data base and clinical data tabulation. Ability to communicate technical concepts clearly and concisely to non-technical colleagues.

Requirements:

  • Bachelor's of Science in statistics or related field.

  • Typically requires 8 years of experience in programming and analyzing the clinical trial data in clinical research organization (CRO), pharmaceutical, or biotechnology industries.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Occupational demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

EEO Women/Minorities/Veterans/Disabled

Req ID: 475790

DirectEmployers