Sr Principal Analyst, Statistical Programming

About This Role

The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internal teams and 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. He/She partners with Biostatistics to deliver high quality, submission‑ready statistical outputs.

This person is also responsible for providing input to the Statistical Programming Portfolio Lead on overall study timelines, monitoring and meeting agreed upon program milestones, escalating issues as needed to their DM counterpart and estimating resource needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management. This includes communication and quality oversight of the vendor.

He/She is comfortable representing the Statistical Programming perspective to the study team or Clinical Development Team and is often the sole functional representative.

The Senior Principal Analyst, Statistical Programming helps implement the Data and Programming Strategy, provides input to the Data Standards personnel and DM on the strategic direction of the program, partners with the PL to ensure appropriate statistical programming standards implementation and serves as a reference for the study to Data Standards personnel. He/She develops and implements standard programming practices while also ensuring that they are employed across a study or program.

He/She collaborates on tools and process improvement for Statistical Programming.

This is a hybrid position that requires in‑person workdays at our facilities in Cambridge, MA.

• Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects via internal and/or external staff oversight.
• Considered a statistical programming expert within the department. Authors CDISC ADaM (analysis data model) analysis data set specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming endpoint algorithms across a study, drug program and/or contributing to TA level algorithms.
• Manages the end‑to‑end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (input to reviewer’s guides, annotated CRF, define and XPTs), works with SMEs to ensure compliance to eSUB standards.
• Identifies process inefficiencies and leads efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
• Serves as the Statistical Programming Lead to achieve milestones for a drug program; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
• Verifies program consistency and usage of data, analysis and submission standards across the department in consultation with data standards, statistical submissions management and the data strategy plan.
• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.

You are a senior principal analyst with strong statistical programming skills to effectively lead and collaborate across functions. You pay close attention to detail and have the proven ability to manage competing priorities. You believe in and live by Biogen’s culture essentials in pioneering, thinking broadly, driving results, ethical and inclusive behavior.

• Bachelor’s degree required;
  Master’s or PhD in Statistics or Mathematics preferred.
• 10 years relevant work experience within an organization with a focus on data management and analysis.
• 10+ years SAS Base programming experience with 7+ years using SAS STAT, GRAPH and MACRO.
• 10+ years relevant industry experience.
• 10+ years clinical trial experience.
• 5+ years clinical database experience.
• CDISC and/or submissions experience.
• Extensive knowledge…