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Posted: Monday, March 13, 2017 10:46 AM

External Posting TitlePrincipal Analyst, Statistical Data Standards (ADaM)Job DescriptionThe Principal Analyst, Data Standards, drives the development, implementation, and maintenance of Biometrics’ clinical data standards capabilities and governance framework. He/She serves as a leader in guiding governance processes for data standards, supporting the establishment of a strategy consistent with Biometrics and Global Development goals.•Supports standards governance framework that supports data standards strategies and processes in alignment with the vision developed by Data Standards and Governance, DS&O Leadership, and industry-based standards policies and procedures•Serves as SME in defining best practices for BIIB implementation of standard models (e.g., CDASH, SDTM, CT, ADaM, Define.xml) to ensure drug submissions compliant with industry regulations.•Applies an industry-facing focus to foster a consistent approach to employ clinical data standards and address governance requests.•Leads or participates in cross-functional teams to coordinate data standardization efforts across Biometrics and other impacted Global Development functions.•Acting as a consultant, he/she supports and educates colleagues across Biometrics and clinical study teams and participates in external industry data standards development teams as appropriate, contributing to the development of clinical data standard models on CDS’ behalf. Communicating across Biometrics and clinical study teams is a critical component of this role.Principal Accountabilities:•Serves as SME in defining best practices for BIIB implementation of standard models (specifically ADaM), ensuring submission compliance. Manages governance processes for data standards models. Facilitates the implementation of data standards strategies within Biometrics and other functions as needed. Leads and/or participates in cross-functional initiatives to improve standards integration within the clinical data flow.•Supports effort to develop and implement data standards governance framework, including governance body that will establish and manage governance processes for data standards models. Proactively identifies and manages critical governance issues, risks, and corrective actions.•Consults with teams to facilitate improved decision-making and problem-solving to aid in consistent application of ADaM/SDTM data standards.•Represents Biogen and Biometrics 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 Biometrics and other functions within Global Development as well as externally. Creates training content for data standards execution.•Develops best practices for data standards incorporation into vendor models. Partners with vendors to ensure successful implementation.LocationCambridge, MA, USJob CategoryBiometricsRequisition Number30719BRQualifications•8+ years relevant work experience with a focus on data management and/or data analysis•3-5 years in-depth data standards experience, Minimum of 1 year ADaM experience•Strong knowledge of clinical data standards, regulatory and drug submission requirements and current regulatory trends including global landscape•Deep understanding of drug development and biopharmaceutical industry required•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•Excellent oral and written communication and presentation skills•Demonstrated problem solving and conflict resolutionEducation•Bachelor’s degree required.About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.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.Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts..

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