Remote ADaM Expert Consultant, one year renewable contract

Remote ADaM Expert Consultant, one year renewable contract

RESPONSIBILITIES:
Lead the development of ADaM data standards
Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation
Develop and maintain Data Element Standard (DES) content and ADaM Implementation Guidance and documentation
Author/Maintain developed ADaM Implementation Guides and implementation examples and update metadata repository
Ensure that decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry guidance
Maintain current knowledge of all FDA, PMDA or other regulatory agency submission requirements and guidance documents pertaining to analysis datasets, metadata and versions accepted
Provide input to continuously improve the management of ADaM standards and metadata
Lead a collaborative team of subject matter experts with representation from all TAs
Provide a single and consistent adoption and implementation of ADaM standards
Provide training of implementation of ADaM
Provide advice on how new and ongoing projects within orginization might best begin to use ADaM standards and how/when existing projects might need to up-version
Review all changes and additions to SDTM standards due to maintenance or new CDISC versions to ensure that all ADaM input derivations and content based on SDTM are complete, correct and up to date
Act as a point of contact to study teams and provide advice as needed on ADaM implementation
Review study level ADaM dataset specifications
Attend study team meetings
Discuss and resolve compliance issues including the dispositioning of Pinnacle 21 issues
Interface with statistical programming groups developing automation for define.xml, analysis dataset and TFL production
Ensure standard DDTs are kept up to date with GSP standard template and evolving define.xml requirements
Ensure that analysis standards can be applied broadly
When requested, participate in internal meetings
Provide expert opinion on difficult ADaM implementation issues
Explain ADaM concepts and reasons why a certain implementation approach is preferred
Represent organization on the CDISC ADaM team

KEY SKILLS / KNOWLEDGE:
In depth knowledge/experience of data collection and reporting in drug development and clinical trials processes
Experience with a variety of study designs, TA’s, and analysis methods
Experience of implementing ADaM data standards in a practical setting
ADaM-IG v1.1 and v1.0 practical knowledge
ADaM metadata practical knowledge
Solid knowledge of SDTM and CDISC TAUGs
Solid knowledge of define.xml
Aptitude for data standards and data standardization
Excellent verbal and written communication skills
A general understanding of the metadata requirements for analysis results and for ADaM datasets
Collaborating in global cross-functional teams
Knowledge of project management, documentation writing, training, and compliance
Use of software and data applications within drug development
Knowledge of computer programming, preferably SAS or other procedural languages
Appreciation of computer system architecture and hardware

QUALIFICATIONS:
Bachelor’s degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline or equivalent combination of education and experience.
8+ years knowledge/experience in Pharmaceutical / Biotech industry
Demonstrated effective communication skills (written and oral)

PREFERRED QUALIFICATIONS:
Master’s degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline
10 years’ work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena
3+ years’ experience in a global organization
Demonstrated ability to influence decision making
Development of policies and SOPs