Job Description
The Principal Analyst, SDTM Data Standards, drives the development, implementation and maintenance of clinical data SDTM standards capabilities. Successful candidate serves as an SDTM SME in defining best practices for Biogen's implementation of standard models (e.g. CDISC SDTM, Controlled Terminology, Define.xml) to ensure drug submissions are compliant with industry regulations. The candidate will work very closely with SDTM Leads and be able to provide detailed SDTM mapping guidance for EDC and complex third party data and execution of SDTM governance requests. He/she leads or participates in cross-functional teams to coordinate data standardization efforts across the Quantitative Sciences and Development Organization (QSDO) and other R&D functions. He/she will be instrumental in facilitating the rapid expansion of Therapeutic Area (TA) standards to enable end-to-end data flow optimization. Acting as an SDTM consultant, he/she supports and educates colleagues and clinical study teams across QSDO. He/she participates in external industry data standards development teams, as appropriate, and contributes to the development of clinical data standard models on QSDO's behalf. Experience enabling metadata driven automation capabilities and tool integrations is a plus.
Principle Responsibilities
- The candidate will work very closely with SDTM Leads and be able to provide detailed SDTM mapping guidance for EDC and complex third party data and execution of SDTM governance requests. Serves as SME in defining best practices for Biogen implementation of standard models (CDASH, SDTM, CT, Define.xml) and ensuring submission compliance.
- Leads the development and rapid expansion of SDTM Therapeutic Area standards to enable efficient study development and the optimization of the end-to-end data flow (i.e. from CDASH to SDTM with appropriate overarching Controlled Terminology).
- Consults with teams to facilitate improved decision-making and problem-solving to aid in consistent application of data standards.
- Represents Biogen and QSDO on external industry-facing data standards development teams. Participates in external initiatives to proactively adopt industry trends and anticipate regulatory needs.
- Coordinates communication and education with internal stakeholders across QSDO and other functions in R&D.
- Creates and delivers training content, newsletters etc. to support SDTM standards awareness, adoption, utilization and compliance.
Who You Are:
You are person who considers themselves an SDTM Subject Matter Expert. You are someone who is passionate about data, data structures, data transformations and standardization of clinical data. You are active in contributing to the CDISC working groups/community.
Qualifications
- 6+ years relevant work experience with a focus on data management, statistical programming or data sciences.
- 4+ years in-depth data standards experience
- Strong knowledge of CDISC standards, regulatory and drug submission requirements and current regulatory trends including global landscape
- Deep understanding of drug development and biopharmaceutical industry
- Programming experience in SAS, R is a plus
- Strong project management skills, and the ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities
- Excellent oral and written communication as well as effective presentation skills
- Demonstrated problem solving and conflict resolution
Education
Bachelor's degree required.
Additional Information
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.