Senior Statistical SAS Programmer, Oncology, Clinical Trials

il y a 4 semaines


Paris, Île-de-France MAI Fortrea Development Limited Temps plein

As a leading global contract research organization (CRO), Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

As a Senior Statistical SAS Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of complex clinical trials (phases I-III) for renowned, innovative, and global top pharmaceutical companies.

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.

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.



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