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About Certara 
Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.    

Certara is looking for Associate Director, CDISC Consultant to support our integrated drug development team.  The Associate Director will provide leadership for our Pinnacle 21 platform to perform a variety of CDISC services related to data fitness assessment, CDISC compliance, and define package to name a few. The successful candidate will ensure timely completion and high quality of all required deliverables.

Responsibilities

• Provide consultative services to P21 clients by helping them with implementation of industry standards (e.g., CDISC) including development and maintenance of client’s internal data standards
• Consult customers on best practices by reviewing existing processes and providing recommendations for improvement
• Produce final define packages (containing define.xml, reviewer’s guide, etc.) for SDTM and ADaM.
• Develop specifications for CDISC compliant SDTM domains and ADaM datasets.
• Develop SAS programs to convert clinical and non-clinical studies data into SDTM datasets and ADaM datasets per specifications.
• Proposing and leading the implementation of new standards
• Developing, managing, and implementing validation rules for data standards and regulatory requirements
• Proposing and leading the implementation of new tools and functionality enhancements of existing systems
• Testing the Pinnacle 21 tools by their active use
• Conduct User training and knowledge transfer

• BSc, MSc or equivalent in Statistical Programming, Biostatistics/Statistics/Mathematics/Bio-Informatics, or related fields with a minimum of 6 years’ experience in data programming, analysis, and reporting within the context of drug development projects.
• Experience with Pinnacle 21 Enterprise
• Minimum 3 years’ experience in biostatistics and/or regulatory submission
• Experience within CDISC, SDTM mapping and/or creation of ADaM datasets, and define.xml files
• Proficient with SAS or R programming
• Strong interpersonal, communication, writing, presentation and facilitation skills
• Detail-oriented with exceptional follow-through and superior organizational skills
• Ability to communicate with technical teams (e.g., developers and engineers) effectively to drive effective issue resolution
• Proven ability to work both independently and as part of a team; experience working as part of a distributed team
• Must combine the ability of working smart and leveraging your team to get things done
• Membership and participation within clinical trials industry user groups
• Experience within successful implementations of CDISC Standards and preparation of study data for regulatory submissions
• Willingness and ability for continuous professional development
• Demonstrated knowledge of clinical drug development.
• Familiarity with project planning tools such as MS Project or similar and concepts such as task dependencies.
• Alternate combination of education, experience and training may be considered.