Principal Analyst, Statistical Programming

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

About this role

As the Senior Analyst, Statistical Programming, you will lead and oversee statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. 

You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs. 

You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line 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. 

You will help to implement the Data Strategy, provide input to the Data Strategy Lead and DM lead on the strategic direction of the study to ensure appropriate statistical programming standards implementation and serve as reference for the study to the 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.

What you’ll do

• Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects.
• Author CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. Work with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
• Manage the end-to-end programming of deliverables from Case Report Form (CRF) collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs); works with Subject Matter Experts (SMEs) in Statistical Submissions Management (SSM) to ensure compliance to ESUB standards.
• Serve as the Statistical Programming Lead to achieve milestones for a study; collaborate with PL and/or manager on issues or resource needs. 
• Verify program consistency and usage of data, analysis, and submission standards within a study in consultation with data standards, statistical submissions management and the data strategy plan.
• Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

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.
• 5+ years relevant work experience within an organization with a focus on data management and analysis
• 5+ years SAS Base programming with 5+ years using SAS STAT, GRAPH and MACRO
• 5+ years relevant industry experience
• 5+ years clinical trial experience
• 3+ 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 (EMEA)/Rest of the World (ROW) guidelines.
• Some familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a