SDTM Programmer

Job Description

About This Role

The Study Data Tabulation Model (SDTM) Programmer will be part of the SDTM Development and Operations organization that is evolving and responsible for fulfilling all of Biogen’s SDTM needs with presence in the Unites States and Europe.

What You’ll Do

You will lead study level SDTM programming activities and deliverables (annotated Case Report Form (aCRF), specifications, datasets, define.xml, Study Data Reviewers Guide, etc.). Collaborating cross-functionally within Analytics and Data Science, you will work other study leads within the Biometrics organization to ensure timely and quality SDTM deliverables for the study.  The SDTM Lead will represent SDTM Development and Operations (Dev & Ops) in the Biogen Portfolio Disease Unit (DU) discussions. This role will ensure quality SDTM package delivery to the Statistical Programming group through programming and oversight of the study SDTM activities.

Who You Are

• A Clinical SAS Programmer with some Lead experience or looking to lead a study
• Someone who is passionate about data, data structures, data transformations and taking/learning about initiatives using Analytics to optimize the transformation of clinical data.
• Experienced in SAS and keen to explore technologies beyond SAS in the clinical trial space.

Qualifications

Required Skills

• Bachelor’s degree
• 2+ years relevant work experience with a focus on SDTM and statistical programming
• 2-5 years proven data standards experience with a focus on SDTM and end to end data flow
• Pharmaceutical/biotechnology/CRO industry experience
• Good knowledge of clinical data standards, regulatory submission requirements including current global landscape
• Working cross functionally with Biometrics stakeholders

Additional Information

The base compensation range for this role is $75,000 - $116,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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.