Statistical Programmer

Grifols

Dublin, Ireland

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, Grifols statistical tables, listing, and figures standards for the medical research report and for regulatory submissions.

KEY RESPONSIBILITIES

The duties and responsibilities include, but are not limited to, the following:

Manages and coordinates the programming activities in clinical trials to ensure the timely completion and the quality of the analysis result presentation.
Generates and validates statistical analyses (tables, listings, and figures) using SAS, R or 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.
Acts as a lead programmer, generating/validating CDISC compliant statistical analysis database and outputs (i.e., tables, listings, figures, and inferential statistical output) using SAS, R 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.

KEY COMPETENCIES

Expert knowledge of SAS, R or Python.
High degree of expertise in CDISC and other industry standards, tools and regulatory requirements.
Excellent knowledge of medical and statistical terminology.
Strong organization, analytical, verbal and written communication skills.
Demonstrate a high degree of independence and technical skills, with minimal to no supervision.
Excellent interpersonal, verbal and written communication skills.
Strong attention to detail and excellent organizational skills.
Comfortable working in a dynamic, fast-paced environment.

Qualifications and Experience

Bachelors’ degree or higher in computer science, bioinformatics, biostatistics or related field.
Requires an MSc with a minimum of 6 years of clinical development experience in the pharmaceutical/biotech industry or a BSc with a minimum of 8 years’ experience.

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