Senior Principal Statistical Programming - FSP
Covance Inc
Bucharest, Bucharest, Romania
3 zile în urmă

Job Overview :

  • Senior Principal Statistical Programmer required to work for Covance, office based or home based anywhere in Europe
  • You will be employed by Covance and work within our FSPx department working across multiple Sponsors to provide technical solutions to improve efficiency and working practices
  • Role will be split between billable activities (programming on studies) and as EU point of contact for the technical innovations group.
  • You must have previous experience as a Principal Statistical Programmer within a biotech, CRO or pharma company
  • Strong technical background in SAS (and ideally also R / Python)
  • Opportunities to develop and progress
  • Discover new opportunities to grow your career as a Covance FSP Senior Principal Statistical Programmer. We are looking for an experienced and strong technical Statistical Programmer with experience in SAS as well as R and Python (ideally).

    As well as programming on studies you will be flexible and agile and develop innovative programming solutions for multiple sponsors.

    If you are looking to strengthen your technical expertise whilst gaining exposure to a pharmaceutical working environment this is a fantastic opportunity.

    This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere in Europe.

    What is FSP?

    At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

    As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor.

    Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

    Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

    With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.

    Job Primary Functions

  • Develop and maintain SAS programs to create complex SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs
  • Produce Define XML / PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Develop and / or lead the development of complex specifications for SDTMs and ADaM datasets and contribute to the development of Covance and Client standards
  • Review SAPs and TFL shells from a programming perspective for studies and advise on the development of complex TFL shells from a programming perspective
  • Mentor programmers in the processes around SDTMs, ADaMs and TFLs and Study Lead processes, ensuring adherence to department practices and processes
  • Leverage advanced technical expertise towards developing innovative programming solutions and facilitating reporting to senior management
  • Respond to QA and client audits and represent the department in all types of audits
  • Participate in partnership Bid Defenses in order to win new packages of business
  • Continually identify and suggest ways to improve the efficiency, quality and productivity of statistical programming
  • Education / Qualifications :

  • BSc, preferably in computing, life science, mathematical or statistical subject
  • Experience :

  • Extensive experience as lead statistical programmer on complex studies in clinical research
  • Substantial knowledge of all aspects of clinical trials from initial study set-up to study completion. Complete knowledge and understanding of the processes and procedures used within a Statistical Programming environment and the ability to communicate to programmers and non-programmers alike.
  • Broad knowledge of all CDISC requirements related to SDTM and ADaM, including define.xml, Reviewer's Guide and submission standards
  • Strong technical SAS experience
  • Ideally have strong technical experience in R and Python
  • PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE

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