Sr. Principal Analyst, Statistical Programming

Job Description

Duties:

• Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of study projects by developing or applying statistical theory and methods to organize, interpret, and summarize numerical data to provide usable information.
• Lead and oversee statistical programming activities  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. 
• Partner with Biostatistics to deliver high quality, submission-ready statistical outputs.
• Provide input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitor and meet agreed upon program milestones, escalate issues, and estimate resource needs.
• Lead a drug program team of statistical programmers to accomplish tasks and communicate issues to senior management, including communication and quality oversight of the vendor.
• Represent the Statistical Programming perspective to the study team or Clinical Development Team and serve as the sole functional representative.
• Develop and implement standard programming practices and ensure that they are employed across a study or program.
• Author CDISC ADaM (analysis data model) analysis data set specifications including identifying potential data issues, and work with statistics to define and document programming endpoint algorithms across a study or drug program.
• Manage the end-to-end programming of deliverables from CRF collections through electronic submission including preparation of electronic submissions (eSUB) components, and work with SMEs to ensure compliance to eSUB standards.
• Verify 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.
• Inform internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
• Telecommuting permitted up to 100%.

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Qualifications

Minimum Requirements:

Bachelor’s degree or foreign equivalent in Statistics, Mathematics, a Life Sciences discipline, or a related field and 7 years of clinical trial experience in the job offered or a Statistical Programming-related occupation in the pharmaceutical or biotechnology industry.  

Experience must include:

7 years of experience with each of the following:

• Using SAS Base Programming, including SAS STAT, GRAPH, and MACRO.
• Working in organization with a focus on statistical programming management and analysis.
• Working with clinical data to produce Standard Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets.

5 years of experience with each of the following:

• Knowledge of industry and regulatory data standards: Clinical Data Interchange Standards Consortium (CDISC) including SDTM and ADaM.
• Knowledge of regulatory submission requirements for submitting data to regulatory agencies including ICH guidelines.
• Knowledge of the drug development process and clinical trials.
• Cross-functional facilitation leading and managing teams in a matrixed organization across multiple locations and organizational functions.
• Managing multiple projects simultaneously, managing conflicting priorities, and demonstrating flexibility when priorities change.

3 years of experience with:

Familiarity with UNIX or LINUX.

Additional Information

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

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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.