Clinical Data Standard Consultant

US-AnywhereRemote in Blue Bell, PA
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in biometrics standards
  • Undergraduate degree or international equivalent
  • Expertise in CDASH and SDTM standards
  • Solid understanding of CRF design concepts
  • Strong leadership and communication skills

Responsibilities

  • Serve on Sponsor Standards and Technology Leadership teams
  • Consult with clients on CDISC-centric implementation
  • Participate in industry standard development groups
  • Author and maintain Standards Related Project Plans
  • Implement strategy for managing CDISC-related metadata
  • Mentor Clinical Data Standards Consultants
  • Identify and recommend process improvements based on metrics

Benefits

  • Competitive base salary and performance incentives
  • Health and wellbeing programs including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance and wellbeing resources
  • Learning and development through structured training
Full Job Description
Senior Statistical Programmer

A Principal Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the define.xml capture for statistical analysis within the Medidata standard. They will develop tools to increase the efficiency, timeliness and quality of deliverables for data collection, tabulation, analysis and reporting. They will also define and collect metrics about the use of standards. They will participate in the development of training of the operational staff in the areas of their expertise.

What You Will Do:

Serve on Sponsor Standards and Technology Leadership teams.

Consult with clients on sponsor-specific CDISC centric implementation projects.

Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.).

Author, maintain, implement, and report status for Standards Related Project Plans.

Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards.

Mentor Clinical Data Standards Consultants. * Lead Subject Matter Expert teams on topics relevant to standards.

Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting.

Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.

Your Profile:

• Minimum of 5 years of experience in industry in a role demonstrating knowledge of standards used by biometrics.

• An undergraduate degree or international equivalent from an accredited institution

• Demonstrated expertise in CDASH, SDTM standards and associated controlled terminology with a good understanding of CRF design concepts.

• Excellent communication skills with demonstrated leadership ability.


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our to read more about the benefits ICON offers.

About Pharmaceutical Research Associates, Inc

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Joining Pharmaceutical Research Associates, Inc presents an unparalleled opportunity to become part of a leading team in the pharmaceutical research industry. This company stands as a beacon of innovation, leadership, and professional growth.

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At Pharmaceutical Research Associates, Inc, the culture thrives on diversity, innovation, and a commitment to employee growth. The company offers comprehensive benefits designed to support the health, well-being, and financial security of each team member. From diversity training to leadership programs, employees are equipped with resources to thrive both professionally and personally.

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For those starting their career journey, Pharmaceutical Research Associates, Inc provides robust internship programs. These opportunities allow interns to work alongside experienced professionals, gaining invaluable industry insight and enhancing their resume through practical, hands-on experience.

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Career advancement is a cornerstone of employment at Pharmaceutical Research Associates, Inc. The company supports career growth through professional development programs, networking opportunities, and leadership training, ensuring that every team member has the tools to succeed.

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Pharmaceutical Research Associates, Inc is at the forefront of pharmaceutical innovation. The team is dedicated to pioneering research that leads to new discoveries and solutions in healthcare, offering employees a chance to contribute to meaningful projects that push industry boundaries.

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