Role overview

Qualifications

Minimum Bachelor’s degree in mathematics, statistics, computing, life science, health science, or related subjects
Typically, 1 - 2 years of SAS® programming experience in the CRO or Pharmaceutical industry
Knowledge of CDISC requirements
Business fluency in English – both spoken and written

Responsibilities

Assume the role of a Lead Statistical Programmer for CP studies with support from senior programming staff
Plan, execute, and oversee all programming activities on a study including resource estimation, budget, timelines, and quality
Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviews Guides

Key facts

Remote from: Estonia, Latvia, Ukraine, Hungary, Bulgaria, Romania, Slovakia, Czechia, Slovenia, Serbia
Full time
Mid-level (2-5 years)
English

Hard skills

SAS (Software) Clinical Trials Project Management Budget Management

Other skills

Quality Assurance
Communication
Teamwork
Problem Solving
Time Management

About the company

Fortrea

Contract Research Organizations (CRO)

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.

Company details

Company typeXLarge

IndustryContract Research Organizations (CRO)

Company size10001

Links

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Job description

As a Statistical Programmer II 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.

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

Your Responsibilities:

With sufficient experience assume the role of a Lead Statistical Programmer for CP studies only with support from senior programming staff.
Plan, execute and oversee all programming activities on a study, including but not limited to, resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs and Reviews Guides to support SDTMs and ADaMs.
With support from senior programming staff, develop specifications for SDTMs and ADaM datasets.
Review SAPs and TFL shells from a programming perspective for studies with support from senior programming staff.
Respond to QA and client audits with support from senior programming staff.
And all other duties as needed or assigned.

Your Profile:

Minimum Bachelor’s degree, preferably in mathematics, statistics, computing, life science, health science, or related subjects.
Typically, 1 - 2 years of SAS® programming experience in the CRO or Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Knowledge of CDISC requirements.
Business fluency in English – both spoken and written – is a must.

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