Principal Analyst - Statistical Programming

Job Description

About this role

The Principal Analyst - Statistical Programming leads and oversees 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. 

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 Development Unit Lead on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their Data Management 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 Lead on the strategic direction of the program, partner with other functional Leads to ensure appropriate statistical programming standards implementation and serve as reference for the study to the 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 have strong statistical programming skills and strong attention to detail. You have proven ability to manage competing priorities.

Qualifications

Required Skills:

• Bachelor’s degree required. Master's or PhD degree in Statistics or Mathematics preferred.
• 7+ years relevant work experience within a Pharmaceutical/Biotech organization (or CRO) with a focus on data management and analysis required.
• 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH, and MACRO required.
• 7+ years clinical trial experience required.
• 5+ years clinical database experience required.
• CDISC and submissions experience required.
• Knowledge of drug development process required.
• Knowledge of drug submission requirements, and relevant ICH and FDA/EMEA/ROW guidelines required.
• Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages) required.
• Ability to effectively lead and collaborate across functions required.

Additional Information

The base salary range for this position is $113,000 – $151,000. Base salary offered is determined though an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.  Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.   

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:  

• Medical, Dental, Vision, & Life insurances 
• Fitness & Wellness programs including a fitness reimbursement   
• Short- and Long-Term Disability insurance  
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) 
• Up to 12 company paid holidays + 3 days off for Personal Significance 
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit 
• 401(k) program participation with company matched contributions 
• Employee stock purchase plan   
• Tuition reimbursement of up to $10,000 per calendar year   
• Employee Resource Groups participation   

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.