The data standard consultant is responsible for statistical programming activities in support of Data Standards stewardship across all compounds/vendors, including collaboration within Data Sciences, Clinical Development, and other functional representatives to develop, maintain and document clinical data standards. This role also acts as a statistical programming subject matter expert (SME) to support outsourced/internal SDTM programming activities, including the data standards technical decision-making to oversee and ensure the quality and timely delivery of SDTM deliverables. He/she will also consult or support development and dependencies across other related Data Standards (i.e., Analysis Dataset models). He/she will support the overall planning, governance and oversight of data standards activities to ensure proper utilization and adherence of data standards.

**Key Responsibilities**

+ Provides technical and/or operational guidance in the application of industry clinical data standards within the statistical programming data flow (i.e., SDTM, ADAM, DEFINE) for clinical studies, drug programs, and/or in support of drug application submissions

+ Provides data standards governance support in alignment with the vision developed by the Sponsor's Data Standards Council, department Leadership, and industry-based standards policies and procedure

+ Ensures study or program-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity

+ Participates on department data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities

+ Participates in clinical data technology-based initiatives

**Qualifications**

+ Minimum of 5 years’ industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent.

+ Minimum of 3 years data standards experience, specifically SDTM compliance and oversight.

+ Experience supporting Data Standards including data standard governance activities, decision-making and training/communication.

+ Expert understanding of CDISC standards; including but not limited to CDASH, SDTM, ADAM, Controlled Terminology, DEFINE.

+ Experience working with managing data standards using a Meta Data Repository preferred.

+ Excellent written and oral presentation and interpersonal, organizational, analytical, project management and multi-tasking skills.

+ Bachelor’s Degree required in areas of computer science, statistics, mathematics or information sciences, MBA, advanced degree and / or Project Management certification preferred.

+ Clear alignment with the sponsor Core Values:

+ Commitment to People

+ Innovation and Discovery

+ Sense of Urgency

+ Open Culture

+ Passion for Excellence

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.