Senior Statistical Programmer - Sponsor Dedicated

Fortrea; Belgique; À distance; EUR 50 000 - 75 000; Plein temps

Résumé du poste

A leading global pharmaceutical firm seeks a Senior Statistical Programmer dedicated to delivering complex clinical trials. This role involves developing and validating SAS programs for data analysis. Responsibilities include reviewing study analysis plans, creating datasets, and improving programming efficiency. Applicants should have a relevant degree and experience in statistical programming within a pharmaceutical setting. Business fluency in English is essential for this home-based or local office position.

Qualifications

• Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company.
• Demonstrated knowledge of SAS and ability to debug SAS programs.
• Business fluency in English is required.

Responsabilités

• Review SAPs and TFL shells from a programming perspective.
• Develop and maintain SAS programs to create SDTM and ADaM datasets.
• Propose innovative ways to improve efficiency and quality.
• Respond to QA and client audits.

Connaissances

Programming in SAS

Statistical analysis

Knowledge of CDISC standards

SAS macros

Quality control in programming

Formation

Degree in mathematics, life sciences, statistics, or computer sciences

Outils

SAS

Description du poste

As a Senior Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative and global top pharmaceutical companies. Oftentimes you will have the opportunity to lead studies through various phases of the clinical development plan and support submissions, regulatory questions, publications as well as ad hoc and post hoc requests.

In this role, you will develop and validate SAS programs for data presentations and analyses and provide programming support to your multidisciplinary global project team. This position allows you to participate in the development of innovative new benchmark drugs for a wide variety of therapeutic areas. Your expertise and your work as a statistical programmer have a direct impact on improving the health and lives of thousands of patients around the globe every day.

You can be 100% home-based or, if you prefer, work from our local office in your home country.

Your Responsibilities

• Review SAPs and TFL shells from a programming perspective.
• Advise on the development of complex TFL shells from a programming perspective.
• Develop and/or lead the development of complex specifications for SDTMs and ADaM datasets.
• Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform quality control of SDTM, ADaMs and TFLs.
• Produce / define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs.
• Respond to QA and client audits and support qualification audits.
• Identify and propose innovative ways to improve the efficiency, quality and productivity of our clinical statistical programming business.
• Maintain awareness of industry standards, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs).

Your Profile

• Degree in a relevant field such as mathematics, life sciences, statistics, computer sciences, etc.
• In lieu of the above: an equivalent completed vocational training and/or equivalent professional experience in statistical programming for clinical trials.
• Solid professional experience as a statistical programmer within a biotech, CRO or pharmaceutical company.
• Demonstrated knowledge of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs.
• Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs.
• Solid knowledge of CDISC standards.
• Submission experience is ideal.
• Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail.
• Business fluency in English – both spoken and written – is a must.

Learn more about our EEO & Accommodations request here.