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:

Statistical Programmer 2

Acts as a lead programmer, generates statistical analysis database and output (i.e., tables, listings, figures, and inferential statistical output) using SAS or other software. Evaluates and participates in the implementation of new technologies/services, and new industrial standards (i.e. CDISC). Supervises and mentors other programmers (internally and externally) for their production work in statistical programming. Participates in the development of departmental processes, working practices, and standard operating procedures.

Statistical Programmer 3

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:

Statistical Programmer 2

Excellent knowledge of medical and statistical terminology. Excellent 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.

Statistical Programmer 3

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 5 years (Programmer 2) or 8 years (Programmer 3) 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.

Pay scale of $90,000-$160,000 per year, depending on credentials and experience. This position is eligible to participate in up to 8% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

EEO Women/Minorities/Veterans/Disabled

Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85

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