Statistical Programmer II - Sponsor Dedicated

Fortrea; Maidenhead; Remote; GBP 40,000 - 65,000; Full time

Job summary

A leading global company in clinical trials is seeking a Statistical Programmer II. You will play a vital role in leading programming activities for clinical studies while collaborating with various departments and ensuring high-quality standards. Ideal candidates should have a Bachelor's degree and relevant SAS programming experience in the pharmaceutical industry.

Qualifications

• 1-2 years SAS programming experience in CRO or pharmaceutical industry.
• Bachelor's degree in relevant fields required.

Responsibilities

• Lead programming activities for CP studies with senior support.
• Develop and maintain SAS programs for SDTM and ADaMs.
• Produce XML/PDFs and metadata for submissions.

Skills

SAS programming

Knowledge of CDISC requirements

Business fluency in English

Education

Bachelor's degree in mathematics, statistics, computing, life sciences or related fields

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. 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 work from our local office in your home country.

Your Responsibilities:

• Assume the role of a Lead Statistical Programmer for CP studies with support from senior programming staff, based on sufficient experience.
• Plan, execute, and oversee all programming activities on a study, including resource estimation, budget management, timeline adherence, quality assurance, and collaboration with other departments and clients.
• 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), annotated eCRFs, and Review Guides to support SDTMs and ADaMs.
• Develop specifications for SDTMs and ADaM datasets with support from senior programming staff.
• 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.
• Perform all other duties as needed or assigned.

Your Profile:

• Minimum Bachelor's degree, preferably in mathematics, statistics, computing, life sciences, health sciences, or related fields.
• Typically, 1-2 years of SAS programming experience in the CRO or pharmaceutical industry, or an equivalent combination of education and experience.
• Knowledge of CDISC requirements.
• Business fluency in English, both spoken and written, is required.

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