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Statistical Programmer

Employer
Grifols
Location
Dublin West, Dublin
Salary
Negotiable
Closing date
30 Nov 2023

View more

Sector
Scientific
Job Type
Permanent
Hours
Full-time

Job Details

 

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

  • 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 programming work in statistical programming. Participates in the development of departmental processes, working practices, and standard operating procedures.
  • Act as a programming functional lead on multiple clinical studies. Determine efficient project programming strategies, utilizing appropriate standards and procedures.
  • Manage the outsourcing of programming activities from Biometry to approved vendors, to ensure quality and timeliness of deliverables.
  • Contribute to initiatives for continual improvement in functional processes.
  • The Statistical Programmer will develop SAS macros, templates and utilities for data cleaning and reporting.
  • 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. .
  • Help Biometry leadership team determine overall programming department strategies to drive the future programming environment within Grifols.
  • Develop programming specifications for integrated studies. Forge partnerships with technical leaders within other functional areas to keep abreast of current best practices in clinical reporting. Along with functional leads, drive the professional development/training and mentoring of programmers 1 - 2 with a view to improving the process and functional methodology. Along with functional leads, drives the strategy for implementation of methods of governance of external vendors.


Who you are

  • You have a Bachelor of Science in statistics or related field.

Statistical Programmer 1

  • 2 years of experience in programming and analyzing the clinical trial data in clinical research organization (CRO), pharmaceutical, or biotechnology industries.
  • Good knowledge of medical and statistical terminology. Good 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 semi-routine assignments following established procedures with moderate direct supervision.
  • Is developing proficiency at demonstrating technical skills, scientific creativity, collaboration with others, and/or independent thought.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Builds productive working relationships internally and externally.


Statistical Programmer 2

  • 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.

 

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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