CDISC Director - Remote

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CDISC Director

India Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Director, CDISC is responsible for overall oversight and management of the Department and will report to Emmes' Chief Scientific Innovation Officer. Preferred candidates will have expert knowledge of CDISC standards, past management experience, and extensive involvement in clinical trial data submissions to the FDA.

Responsibilities
  • Supervision, Management, and Oversight of the CDISC Department
  • Direct supervision and performance review of staff including assignment and utilization
  • Training and development of staff including management of the Department's Professional Development budget
  • Manage resource projections for the Department based on existing projects and upcoming projected work
  • Lead interview and hiring activities for the Department including decisions regarding new hires
  • Support proposals and business development with assumptions and budgets for CDISC activities and maintain stock CDISC proposal language and customize as necessary for new business proposals
  • Ensure quality of CDISC submissions to clients and/or regulators
  • Strategic planning for CDISC efforts and submissions based on client expectations, product development plans, internal resources, current standards, projected new work and agencies involved
  • Determine timelines, resources, and expertise necessary to generate CDISC data structures and supporting materials
  • Communicate with project management regarding timelines, changes to timelines, and any organizational or technical challenges as they arise
  • Direct technical support including: Protocol and CRF review, Development or review of DEFINE.XML, development and review of SDTM mapping, development and review of ADaM mapping, development or review of Reviewers Guides, development or review of Study Data Standardization Plans
  • Authorization of the data components of regulatory submissions
  • Direct client engagement regarding mapping and submission expectations and challenges
  • Management of Corporate CDISC standards and procedures
  • Oversee review and update of internal SDTM and ADaM Implementation Guides as necessary including determination of need for new domain, therapeutic-area or other specialized Implementation Guides to ensure quality project support
  • Oversee review and update of internal Controlled Terminology
  • Oversee review and update of internal CDISC Standard Operating Procedures
  • Engage directly with clients, or through project staff, regarding CDISC-only client support
  • Maintain knowledge of competing CDISC service offerings in the marketplace
  • Maintenance of CDISC Expertise and Corporate profile with CDISC
  • Ensure Department is up to date with latest CDISC standards and regulatory requirements/expectations
  • Ensure Emmes remains engaged with CDISC including conference presentation, participation in committees or panels, contribution to new and evolving standards, etc
  • Provide internal training to non-CDISC Department staff

Experience
  • Bachelor's degree and 15 years of relevant experience in Statistics, Statistical Programming, Data Management and/or CDISC Services. Masters or PhD in a scientific/technical discipline preferred along with 10 or more years of relevant experience in Statistics, Statistical Programming, Data Management and/or CDISC Services
  • Possess expert level knowledge of CDISC Standards, particularly theory & application of SDTM and ADaM Standards
  • Possess expert level knowledge of U.S. FDA and International regulations, guidance documents, and regulatory process pertaining to data submission standards
  • Prior demonstrated work history developing and implementing CDISC Implementation Guides
  • Possesses advanced analytical skills with the ability to interpret data/information and its practical application
  • Prior management/supervisory experience required
  • Strategic thinking, leadership skills, assertiveness, strong technical background, good business judgment, integrity, and excellent negotiation and project management skills as evidenced by past performance on product development teams
  • Excellent organizational, planning, analytical, and problem-solving skills. Attention to detail required
  • Ability to build and maintain positive relationships with management, peers, and subordinates
  • Excellent verbal and written presentation and communication skills are necessary. Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity; performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
  • Consistently exercises sound judgement and effectively prioritizes competing tasks in a fast-paced and dynamic environment
  • Possess high degree of initiative and the ability to work collaboratively across teams to describe service group offerings and align management with programmatic needs
  • Sound knowledge in MS Office (Word, Excel, and PowerPoint) and PDF rendering tool


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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