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Study Data Tabulation Model (SDTM) Programmer - Woodcliff Lake, NJ

Job Location: NJ - Florham Park

Regional Description: Northeast

Job Number: 00536259

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- Job description

Join Accenture and help transform leading organizations and communities around the world.  The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance.  Choose Accenture, and make delivering innovative work part of your extraordinary career.
 
People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
 
The Study Data Tabulation Model (SDTM) Programmer in Woodcliff Lake, NJ will be responsible for the development of SDTM, SDTM +, SDTM annotated Case Report Form (CRF) and generation of SDTM datasets for various studies across all therapeutic areas. They will Collaborate with client and Accenture team to define timelines, identify / resolve issues, produce deliverables in accordance with contractual commitments within budget.
 
Key Responsibilities:
  • 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

    Job Requirement:

    Expect 80–100 % on site time at client site in Woodcliff Lake, NJ

     

Basic Qualifications:
  • Bachelor’s degree
  • Minimum 10 years of relevant programming and drug development experience in Clinical Research Organization (CRO), Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials)

Preferred Qualifications:

  • Expertise in CDISC standards and applicability to clinical database design/capture and reporting
  • Excellent Statistical Analysis Systems (SAS) programming skills (at least 5 years SAS experience preferred)
  • Expert knowledge in clinical trials with 5+ years’ 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

     

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

Accenture is a Federal Contractor and 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.

 

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