Principal Programmer, SDTM Development and Operations | Durham, NC

Detailed Information

  • Location: Durham, NC

  • Company: Biogen

in developing and implementing best practices and processes for optimization of the SDTM delivery model. Contribute to training and education of internal and external resources. Review the study pipeline, serve as a first line for routine day-to-day activities for Functional Service Provider resources, and review of metrics related to SDTM quality and timelines.

Ensure quality SDTM package delivery to the Statistical Programming group through oversight of the model. Participate in external teams, forums, or conferences to keep abreast of data standards development and regulatory activities. Telecommuting permitted up to 100%. Qualifications Minimum Requirements : Bachelor's degree

(or foreign equivalent) in Life Sciences, Chemistry, Engineering, or a related field and 5 years of experience in the clinical sciences industry with a focus on SDTM, statistical programming, data analysis, and vendor management.

Position also requires demonstrable experience with each of the following: SAS programming skills. Understanding of SDTM data structures. Proven data standards experience with a focus on SDTM and end to end data flow. Strong knowledge of clinical data standards and regulatory submission requirements including current global landscape. Experience working with vendors. Working knowledge of drug development and biomedical industry. Strong project management

skills and ability to effectively lead and collaborate with various business functions.

High attention to detail including proven ability to manage multiple competing priorities. Effectively communicating technical, statistical, or scientific information orally and in writing, including explaining methodology and consequences of decisions in lay terms tostakeholders. Demonstrated problem solving and conflict resolution skills. 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.

Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual 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. PDN-9ad7cba3-6b1c-4f1f-92cc-30c52164ab44

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