1+ months

Safety Monitoring Programmer - Woodcliff Lake, New Jersey

Florham Park, NJ 07932
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Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

This role resides within Accenture's Applied Life Sciences Solutions group. This group helps clients make a meaningful impact on patients lives by combining new science with leading-edge technology. Were working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered. Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.

Clinical Operations services we provide:

+ Clinical data management services

+ CDISC based clinical data conversion services

+ Biostatistics and statistical programming services

+ Clinical data transparency and disclosure

Accenture data operations professionals leverage their domain expertise for authoring data management plans, EDC database design, data review, reconciliation and coding.


+ Processing and/or authoring of over 6.5 million case files

+ Over 2,000 clinical databases created

+ Over 900 clinical databases locked

Clinical Statistics and Programming services we provide:

+ 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

Regulatory Services we provide:

+ 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

Regulatory Accomplishments

+ 350+ clients

+ One of the largest users of the FDAs electronic gateway

+ Support over 90 countries

Job Description

The Safety Monitoring Programmer in Woodcliff Lake, New Jersey collaborates with the client team to define safety reporting specifications, and program Java-Review reports and listings according to specifications. They provide for integrated study database automation and programming. They assure Ongoing Safety Monitoring System (OGSM) automation, maintenance and programming. Perform Unix Administration and Java-Review maintenance as needed.

Key Responsibilities:

+ Strictly adhere to Accenture Standards (and clients, 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

+ Address technical challenges that connect Statistical analysis Systems (SAS), Clinical Data Interchange Standards Consortium (CDISC) and Extensible Markup Language (XML).

+ Development and implement clinical standards in a global pharmaceutical environment.

+ Integrating SAS with other leading technologies such as XML, Microsoft Office, to support electronic submissions.

+ May annotate Case Report Forms (CRFs) in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.

+ May review and provide quality assurance to CRF annotations produced by other programmers

+ Review and provide quality assurance to datasets and programming specifications produced by other programmers

+ Develop and maintain cross-functional / cross-department processes related to clinical trial data production, including specifications, programming, Quality Control (QC), and deliverables of data for analysis and submission

+ Execute processes related to clinical trial Study Data Tabulation Model (SDTM) data production, including specifications, programming, QC, and deliverables of SDTM data for analysis and submission

+ Engage appropriate stakeholders in communication to create data standards and process for transition of clinical data to SDTM

+ Collaborate with client team to develop dataset requirements for SDTM, SDTM+, in production.

+ May be accountable for datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of datasets, on time and with high quality

+ Provide data production technology consultation to client Clinical Data Operations team related to dataset delivery and manage the activities of a team with a common focus

+ Responsible for Java-Review and Unix Administration and writing Shell Scripts

+ Perform integrated study database automation, programming and maintenance; develop macros as needed

+ Perform Ongoing Safety Monitoring System automation, maintenance and programming

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Safety Monitoring Programmer - Woodcliff Lake, New Jersey

Florham Park, NJ 07932

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