- Clinical data management services
- CDISC based clinical data conversion services
- Biostatistics and statistical programming services
- Clinical data transparency and disclosure
- Processing and/or authoring of over 6.5 million case files
- Over 2,000 clinical databases created
- Over 900 clinical databases locked
- Collaboration with sponsor on Integrated Summary of Effective (ISE) and Integrated Summary of Safety Strategy (ISS)
- Pooling and analysis activities
- ISS/ISE Statistical Analysis Plan (including Mock Table Listings and Figures)
- ISS/ISE Analysis Datasets from pooled and standardized SDTM database
- ADaM Compliance
- Experience representing sponsors or preparing sponsors for FDA Advisory Committee meetings or respective regulatory authority
- Extensive technical knowledge and industry-leading CDISC standards expertise
- Proven track record includes the analysis of over 4,000 datasets
- Clinical Trial and Drug Application Submissions
- Clinical Data Transparency and Anonymization
- RoW Marketing Authorization Submissions
- Document and Dossier Re-formatting
- License Maintenance Submissions
- Dossier Consolidation, Gap Analysis and Remediation
- Submission Continuity Management
- 350+ clients
- One of the largest users of the FDAs electronic gateway
- Support over 90 countries
- Strictly adhere to Accenture standards (and client’s, as applicable) including standard operating procedures, guidance documents, and policies; operational and service level agreements; metrics and quality Measures
- Accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costs and timelines for assigned project(s)
- Support and identify areas for automation & innovation as process enhancements to improve quality of work or efficiencies in ways of working (e.g. continuous improvement)
- Support strategic initiatives and Accelerated Research & Development Services (ARDS) cross functional offerings
- Support client relationship development, account planning and growth
- Act as onsite presence at target account(s) to build and execute client relationship plans
- Annotate CRFs in accordance with Clinical Data Interchange Standards Consortium (CDISC) published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets
- Review and provide quality assurance for CRF annotations, datasets and programming specifications produced by other programmers
- Accountable for development and maintenance of cross-functional / cross-department processes related to clinical trials, SDTM, SDTM+, which may include specifications, programming, Quality Control (QC), and deliverables of SDTM related data for analysis and submission
- Accountable for execution of processes related to clinical trials SDTM, SDTM+ development, including specification, programming, QC, and deliverables of SDTM data for analysis and submission
- Engages appropriate stakeholders in communication to create SDTM standards and process for transition of clinical data to SDTM and SDTM+. Includes Data Transfer Specification (DTS) review for external data
- Collaborate with key stakeholders to understand dataset requirements for SDTM, SDTM+ in production
- Accountable for SDTM datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of SDTM datasets, with high quality and on time deliverables
- Provides SDTM data production technology consultation to client Clinical Data Operations related to SDTM data delivery and manages the activities of a team with a common focus
- Bachelor’s degree
- Minimum of 5 years of SAS programming and drug development experience in Clinical Research Organization (CRO), Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials)
- Minimum of 3 years of experience mapping SDTM domains
- Experience leading teams, preferably in an on-shore/off-shore model
- Expertise in CDISC standards and applicability to clinical database design/capture and reporting
- Expert knowledge in clinical trials with experience working in a clinical project team environment
- Expertise in integrating SAS with other leading technologies such as Extensible Markup Language (XML), Microsoft Office, etc. to support electronic submissions
- Expertise in addressing & resolving technical challenges that connect SAS, CDISC and XML. Manage risks and escalate appropriately
- Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
- Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle preferred
- Knowledge of Pinnacle 21
- Experience in creating reviewer’s guides and Define.xml for SDTM
Accenture is an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.
Equal Employment Opportunity All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
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