Senior Statistical SAS Programmer, Oncology, Single Sponsor

7 maanden geleden

Amsterdam, Nederland MAI Fortrea Development Limited Voltijd

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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 Oncology drugs. Your expertise and your work as a statistical programmer has 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 in EMEA or, if you prefer, you can work from our local office in your home country.

What else can you expect from us?

Rewarding and meaningful work in an established, diverse, highly profitable and respected global company

Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.

A genuine work life balance

Flexibility in working hours

A thorough onboarding with support from your personal mentor

A permanent employment contract with Fortrea

Excellent training and career development opportunities, as well as support with advancing your individual education

Strong support from your Line Manager and your team, as well as from more than 20,000 Fortrea colleagues worldwide

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

Prior experience working on oncology data (safety and efficacy) and/or on vaccine trials

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

REMOTE

#LI-AA3

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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