Job Description

About This Role

The Head of Statistical Programming, Digital and Data Sciences is a member of the Quantitative Sciences & Development Operations (QSDO) leadership team and is accountable for the management and direction of global statistical programming, data stewardship, data transparency, data sciences and applied machine learning, data tools development, clinical trial metadata (SDTM) management, digital data sciences, data engineering and technology platform functions. He/she will work closely with the QSDO LT to develop the digital, data and technology strategy for QSDO, as well as for the broader Development organization.

What You’ll Do

• Manage a team of 60 FTEs and ~100 FSP staff located globally
• Strategic and operational management to support analytical and reporting milestones for studies, programs and submissions across all therapeutic areas and phases of development
• Partnering with Biostatistics, Epidemiology and Real-World Data Analytics to ensure excellence in all aspects of statistical trial reporting and submission deliverables
• Manage and develop analytical tools/applications, including building out multi-language programming capabilities in SAS, R and Python
• Strategic and operational management of analytical programming activities for biomarker data, real world data, digital biomarker and sensor data, genomic data and other types of data analysis outside the typical analysis required for a clinical study report. 

Who You Are

You are a data sciences leader with a passion for innovation and deep expertise across data and analytics with proven ability to deliver and drive transformation in the field. You are an experienced manager who values diversity, equity, and inclusion and who values bringing the best out of others and enabling them to achieve their full potential.  You are a strong leader with a strategic vision to develop novel tools, bringing innovation and flexibility with a high sense of urgency.  You have a marked curiosity about science, medicine, healthcare and business opportunities. 

Qualifications

Required Skills

• Bachelor’s Degree
• 15+ years’ experience in biotech, pharmaceutical, CRO or related industry
• Experience leading teams in the field of quality, technology, IT, programming, statistics and/or related fields in a direct-reporting relationship
• Expert knowledge of clinical data standards (CDISC/SDTM), technologies and systems related to clinical data, and of quality/compliance regulations related to the development of novel therapies.
• Demonstrated success in providing leadership in a regulated environment and in implementing automation solutions for process efficiency .

• Experience interacting with vendors, thought leaders, inspectors, and regulatory agencies
• Excellent organizational, collaboration and communication skills

Preferred Skills

• Advanced/Graduate Degree
• Leadership in robotic process automation and artificial intelligence

• Firm understanding of the uses of cloud-based technologies
• Specific experience in the field of Neuroscience, Rare Disease or Immunology and in global submissions is desirable.
• Prior experience managing activities of external service providers

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.

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. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.