Senior CDISC Consultant

California  ‐ Onsite
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Description

Please review the job description below and reply me with

1. Your updated word copy resume.

2. Best number and time to reach you for further discussion.

Title: Sr. CDISC Consultant

location: Thousand Oaks, CA

Contract - 13 Months (Possible Extension)

  • This position can sit on-site in Thousand Oaks, CA or can be REMOTE.

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
  • 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- MUST HAVE ALL QUALIFICATIONS & ALL TOP SKILL SETS

  • 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
  • 3+ years' experience in a global organization
  • Demonstrated ability to influence decision making
  • Development of policies and SOPs

Why is the Position Open?

This is to back fill someone who recently converted to an FTE.

Top 3 Must Have Skill Sets:

1. SMEs in ADaM (at least 5-7 years developing ADaM standards)
2. Extensive leadership background- Experience coaching, training and leading a team on CDISC ADaM Standards.
3. In depth knowledge/experience of data collection and reporting in drug development and clinical trials processes
4. Experience with a variety of study designs, TA's, and analysis methods
5. Experience of implementing ADaM data standards in a similar setting and coaching, training, and leading others on the standards.
6. ADaM-IG v1.1 and v1.0 practical knowledge
7. ADaM metadata practical knowledge
8. 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/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 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:

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

Employee Value Proposition:

It is a unique opportunity to work with a team of superstars in their industry. We are the top industry standards group. This can also open up other opportunities at Amgen as well.

Possible Extension:

Yes

Red Flags:

Why were previous candidates rejected? "Most of the applicants were programmers and had some knowledge of SDTM but not ADaM. And, if they had some ADaM experience, it was not sufficient. We are looking for SMEs in ADaM (at least 5-7 years working with ADaM) with leadership skills." Grammatical errors and hard to read/understand resumes will be rejected

Interview Process:

Phone interview followed by in-person or skype

.*In case you feel this position is not a fit, do let me know so that I can update you with opportunities based on your preference. I would appreciate if you could help by referring any friends/colleagues who might be interested in the above opportunity..*

Start date
ASAP
Duration
13 months
From
Software Specialists
Published at
01.05.2018
Project ID:
1547875
Contract type
Freelance
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