SUMMARY:
This position will act as the Clinical Data Standards Manager within the Biostatistics and Clinical Data Management (BCDM) group and will be responsible for implementing and maintaining data standards for electronic data sets for Exelixis clinical trials, including studies contracted to CROs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop, implement and maintain Exelixis global data standards for raw clinical trial data sets.
Make decisions in conjunction with senior BCDM staff regarding when project data standards may deviate from Exelixis global data standards.
Uses CDISC SDTM guidance rules to author and maintain mapping specification to convert raw clinical trial data sets to SDTM domains and variables.
Decide which CDISC SDTM domains are required based on raw data and create new protocol-specific and/or supplemental domains when needed.
Supervise CRO implementation of mapping specification to ensure quality, timelines, and budget goals are met.
Plan, oversee, document and participate in validation/QC of SDTM domains and verify metadata to ensure conformance with SDTM Implementation Guidance (IG) and Controlled Terminology, including generation and review of output from software tools such as OpenCDISC
Create data definition files (define.pdf) and annotate CRFs to CDISC SDTM
Communicate and reinforce content and interpretation of SDTM specifications to individual Study Data Managers, Statistical Programmers, and Biostatisticians, including CRO staff, to ensure consistency in understanding and implementation of standards.
Act as a key point of contact for SDTM standards issues
Author SOPs and work instructions as required to govern data standardization activities.
SUPERVISORY RESPONSIBILITIES:
Indirectly supervises employee(s) through a dotted line structure
EDUCATION/EXPERIENCE/SKILLS:
BA/BS in a relevant health science or computer science discipline and minimum experience: 5 – 7 years as a SAS programmer/data manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience.
Strong working knowledge of the CDISC SDTM IG and Controlled Terminology
Demonstrable experience creating data mapping specifications and annotated CRFs
Knowledge of requirements of define.xml and define.pdf
Strong project management skills
Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus.
Good communication skills; ability to work in a team environment with medical personnel, clinical monitors, data managers, clinical programmers, statisticians, and statistical programmers
FDA NDA submission experience
JOB COMPLEXITY:
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Networks with key contacts outside own area of expertise.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job
Position Requirements
Exelixis Inc. - 12 months ago
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