Sr. ADaM Leader

Location: Thousand Oaks, CA
Date Posted: 06-15-2018
Must Have Skill Sets:
  • SMEs in ADaM (at least 5-7 years developing ADaM standards) NOT just following or "ad hearing" to the standards
  • Extensive leadership background- Experience coaching, training and leading a team on CDISC ADaM Standards.
  • 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 similar setting and coaching, training, and leading others on the standards.
  • ADaM-IG v1.1 and v1.0 practical knowledge
  • ADaM metadata practical knowledge
  • This person should already understand that CDISC is a constant evolution- so make sure they are taking necessary steps to remain up to date on their CDISC knowledge. The manager would like to see that they are a regular attendee of CDISC conferences and meetings.

Additional Key skills
  • 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 data sets
  • 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 Suggestions on sourcing strategies-:Advertising on the CDISC website.                            
  • PharmaSUG conference (coming up soon). (if possible) advertise through the CSS Phuse website
Day to Day Responsibilities:
  • Lead the development of ADaM Standards.
  • Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation. lead, coach & train a team on the ADaM Standards (Must have extensive leadership skills)
  • Develop and maintain Data Element Standard (DES) content and ADaM Implementation Guidance and documentation
  • Author/Maintain Amgen developed ADaM Implementation Guides and implementation examples and update metadata repository
  • Ensure that Amgen 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 at Amgen
  • Provide training of Amgen’s implementation of ADaM
  • Provide advice on how new and ongoing projects within Amgen 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 Amgen internal meetings
  • Provide expert opinion on difficult ADaM implementation issues
  • Explain ADaM concepts and reasons why a certain implementation approach is preferred
  • Represent Amgen on the CDISC ADaM team
Qualifications
  • Master’s degree or equivalent in statistics/ biostatistics, programming, life science, computer science, business administration or related discipline
  • 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)
  • 10 years’ work experience in data management, biostatistics or programming in the Pharmaceutical or Biotech arena
  • 5+ years developing the CDISC standards - not just "ad hearing" to the standards
  • MUST have lead a team in the past- only substantial leadership skills will be considered
  • 3+ years’ experience in a global organization
  • Demonstrated ability to influence decision making
  • Development of policies and SOPs
"This posting is for Contingent Worker, not an FTE"
 
or
this job portal is powered by CATS