Offer summary

Qualifications:

Degree in mathematics, life sciences, statistics, computer sciences, or equivalent experience in statistical programming for clinical trials., Solid professional experience as a statistical programmer in biotech, CRO, or pharmaceutical companies., Demonstrated knowledge of base SAS, SAS macros, SAS/STAT, and debugging SAS programs., Strong organizational skills and business fluency in English, both spoken and written..

Key responsabilities:

Review SAPs and TFL shells from a programming perspective.

Develop and maintain SAS programs for SDTM and ADaM datasets and TFLs, ensuring quality control.

Produce XML/PDFs, Analysis Results Metadata, and Reviewers Guides to support datasets.

Identify and propose innovative ways to improve efficiency and quality in clinical statistical programming.

Job description

As a Senior Statistical Programmer in our multi sponsor 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.

Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers!

You can be 100% home-based or if you prefer, you can 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

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