Sunovion Director, Data Standards in Marlborough, Massachusetts

Job Description:

Work to create/maintain Sunovion’s library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the Sunovion data standards targets.

Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other Sunovion R&D functions that process data (e.g. Non-clinical).

Work to create/maintain the Sunovion package of specifications of data requirements to be communicated to CROs and other data processing vendors performing clinical development work for Data Science.

Act as the sole communicator to internal/external resources of Sunovion’s data-related requirements.

Act as liaison between Data Management, Clinical Data Programming, Statistical Programming, and Biostatistics to promote data standardization within Data Science that encompasses raw data, SDTM, and ADaM datasets.

Act as liaison between Data Science and other Sunovion functions such as Medical Writing, Clinical Research, Regulatory, etc. to ensure that clinical trial documents incorporate required standardized terminology to facilitate data acquisition and integration, with minimal reformatting and translation.

Act as liaison between Sunovion and CDISC or other SDOs to communicate Sunovion’s needs regarding new terminologies, reviews of drafts of new/updated standards documents, etc.

Work with Sunovion Regulatory Operations and Project Teams to communicate Sunovion’s data submission plans as part of regulatory filings.

Work with Clinical Data Programming and Statistical Programming to continue the refinement of validation checking on all data deliverables.

Leverage data standards wherever possible to increase efficiency in data processing both internally and at external service providers, regardless of provider.

Job ID: 6197BR

Department: Research & Development

Location: Marlborough, MA

Job Type: Full-time

Summary of Responsibilities: Work to create/maintain Sunovion’s library of company metadata standards, including CRFs, Datasets, Variables, Value List, Controlled Terminology, Computation Method definitions in a single, easy to navigate repository that describes the Sunovion data standards targets.

Work to keep abreast of and incorporate new and updated data standards issued by CDISC and other Standards Development Organizations (SDO) which impact data processing activities within Data Science and other Sunovion R&D functions that process data (e.g. Non-clinical).

Work to create/maintain the Sunovion package of specifications of data requirements to be communicated to CROs and other data processing vendors performing clinical development work for Data Science.

Act as the sole communicator to internal/external resources of Sunovion’s data-related requirements.

Act as liaison between Data Management, Clinical Data Programming, Statistical Programming, and Biostatistics to promote data standardization within Data Science that encompasses raw data, SDTM, and ADaM datasets.

Act as liaison between Data Science and other Sunovion functions such as Medical Writing, Clinical Research, Regulatory, etc. to ensure that clinical trial documents incorporate required standardized terminology to facilitate data acquisition and integration, with minimal reformatting and translation.

Act as liaison between Sunovion and CDISC or other SDOs to communicate Sunovion’s needs regarding new terminologies, reviews of drafts of new/updated standards documents, etc.

Work with Sunovion Regulatory Operations and Project Teams to communicate Sunovion’s data submission plans as part of regulatory filings.

Work with Clinical Data Programming and Statistical Programming to continue the refinement of validation checking on all data deliverables.

Leverage data standards wherever possible to increase efficiency in data processing both internally and at external service providers, regardless of provider.

Essential Functions: • Provide support across Data Science functional areas to promote and enforce the use of company data standards. Maintain metadata libraries of company standards, as adapted from industry standards, to be used by various functional groups performing data processing.

• Establish standards governance framework.

• Review and assess the impact of newly released and updated data standards from SDOs and incorporate into Sunovion’s business practices, as applicable.

• Review and assess the impact of newly released and updated regulatory agency requirements regarding data standards and incorporate into Sunovion’s business practices, as applicable.

• Promote the development of processes, tools and utilities within Data Science that leverage standardized data in order to increase efficiency of data processing, from data acquisition through data analysis, reporting and submission.

• Prepare internal SOPs and SWIs related to the use of data standards.

• Communicate Sunovion’s data requirements to external vendors. Interact with external vendor personnel regarding standardized data transfer specifications, as necessary.

• Interact with SDOs and/or regulatory agencies regarding Sunovion’s data submission requirements and plans.

• Assist with NDA preparation planning as regards the use of CDISC standards.

Minimum Education Requirements: Bachelors

Experience Required: 7 - 10 Years

Knowledge & Skills (General and Technical): • Demonstrated experience in a standards governance capacity.

• Strong knowledge of CDISC SDTM and ADaM models and Controlled Terminology is a requirement.

• Experience creating CDISC SDTM and ADaM datasets is highly desirable.

• Experience with creation and review of CDISC-formatted electronic submission deliverables is desirable.

• Knowledge of CDISC SEND model is desirable.

• Experience working with SDOs or data submission preparers is desirable

• Strong experience with databases or other controlled metadata repositories.

• Strong experience with document maintenance, version control, implementing upgrades, etc.

• Strong communication skills, both oral and written.

• Strong organizational and time management skills and the ability to handle multiple assignments effectively and deal with ad hoc requests.

Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): • Bachelor degree and 7+ years in the pharmaceutical industry, preferably in a data science or regulatory capacity.

• CDISC training/experience is a requirement.

• Demonstrated experience in standards governance capacity.

• Working familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines and industry standards (FDA/CFR, ICH/GCP, CDISCPMDA, PhUSE).

• Experience with implementing/working with metadata repositories/management systems is highly desirable.

• Demonstrated knowledge of current and planned FDA data submissions requirements.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer

Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.