Statistical Programmer

Statistical Programmer

Provides statistical programming support to all Grifols clinical trials and projects and implements and or 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, listings and figures, and standards for the medical research report and for regulatory submissions. The Statistical Programmer will build the appropriate programs in order to create SAS datasets from the clinical database, external data sources and other data sources as outlined in the clinical study's protocol or statistical plans.

What your responsibilities will be

• Manage and coordinate the programming activities in clinical trials to ensure the timely completion and the quality of the analysis results presentation.
• Lead the development and review of SDTM and ADAM data specifications
• Generate and validate SDTM and ADaM data sets and 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 the clinical project team.
• Interact regularly with other team members within clinical development department or in other departments, in identifying, preventing, reconciling potential data issues.
• Maintain 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.
• Perform validation and quality review of deliverables provided by internal or external resources.
• Support the Regulatory Affairs with electronic submission to FDA and other regulatory agencies by preparing the documents under CRT folder with compliance to eCTD guidelines
• Review the programming and data management related documents, e.g.. case report form(CRF) design, Annotation of CRF, edit checks, database structure.
• Plan / conduct programming of data checks to ensure clinical data quality. Establish monitoring of data transfer for ongoing trials to identify study conduct or data quality issues.
• Provide programming support to other functional groups such as Data Management, Medical Writing.
• Responsible for the integrity of programming/computing solutions for multiple clinical projects/trials or publication activities.

Additional responsibilities depending on experience

Who you are

You have a Bachelor of Science in statistics or related field.
Typically requires 5 years of experience in programming and analyzing the clinical trial data in clinical research organization (CRO), pharmaceutical, or biotechnology industries.

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 organizational, 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.

Works on assignments with a diverse scope and varied level of difficulty with limited direct supervision. Routinely demonstrates mastery of technical skills, scientific creativity, collaboration with others, and/or independent thought. This job is the fully qualified, experienced, career-oriented position.

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

What we offer

It's a brilliant opportunity for someone with the right talents. Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.