Principal Analyst, Statistical Programming

  • Full-time
  • Region: US
  • Department: Research & Development

Company Description

At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine

Job Description

What you’ll do

As the Principal Analyst, Statistical Programming, you will partner with Biostatistics to deliver high quality, submission ready statistical outputs. You are responsible for providing input to the Disease Unit (Du) Lead on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their Data Management (DM) counterpart and estimating resources needs.  You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management.  This includes communication and quality oversight of the vendor.  You will represent the Statistical Programming perspective to the study team and is often the sole functional representative. 

As the Principal Analyst, Statistical Programming you will help to implement the Data Strategy, provide input to the Data Strategy Lead and Data Management Operational Lead (DMOL) on the strategic direction of the program, partner with the Digital Standards & Governance (DS&G) Lead to ensure appropriate statistical programming standards implementation and serve as reference for the study to the Analytics and Data Sciences (ADS) Data Sharing representative.  You will develop and implement standard programming practices while also ensuring that they are employed across a study. You will collaborate with technical programming on tools and process improvement for Statistical Programming.

Who you are

You are a Senior Analyst with strong statistical programming skills who pays close attention to detail and have the proven ability to manage some competing priorities

Qualifications

Required Skills:

  • Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
  • 7+ years relevant work experience within an organization with a focus on data management and analysis
  • 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
  • 7+ years relevant pharmaceutical/CRO industry experience
  • 7+ years clinical trial experience
  • 5+ years clinical database experience
  • CDISC and/or submissions experience
  • Knowledge of drug development process and clinical trials
  • Knowledge of drug submission requirements, relevant International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Food and Drug Administration (FDA)/ European Medicines Evaluation Agency (EMA)/Rest of the World (ROW) guidelines.
  • Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
  • Management skills, and ability to effectively lead and collaborate across functions 

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

All your information will be kept confidential according to EEO guidelines.

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