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Clinical Programmer (SAS / SDTM)

Pyramid Consulting, Inc.

This is a Full-time position in Berkeley Heights, NJ posted March 28, 2020.

Immediate need for a Job title Clinical Programmer (SAS SDTM) experience in the Pharmaceutical Industry.

This is 12 Months Contract position with possible extension located in Berkeley Heights, NJ.

Please review the job description below JOB ID 20-09284 Responsibilities will include, but are not limited to Key Responsibilities Primarily responsible for quality and timely delivery of SDTM artifacts (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF) for Client studies Serve as Study SDTM Programming lead for all regulatory submissions Expertise in Client SDTM automation tools, macros and using them for SDTM programming Strong understanding of Client EDC, SDTM metadata and metadata driven Review the Study EDC specification and ensure all collected study data (including external) is mapped appropriately in target SDTM model Design the SDTM specification as per the CDISC SDTM IG and ensure they meet downstream ADaM and Reporting requirements Annotate CRFs and Review annotated CRFs in accordance with Client guidelines and appropriate metadata to reflect tabulation datasets Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Client Quality tools Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues Represent SDTM Programming function in Study team meetings as well as cross-functional working groups and process improvement activities Provide subject matter expertise in defining the mapping relationships between source EDC and target SDTM domains Support and identify areas for automation innovation as process enhancements to improve quality of work and efficiencies Remain abreast with latest industry trends in standards implementation, review published papers and participate in industry conferences Direct responsibility preparing and presenting SDTM information cross functionally Resolve problems as they arise within defined procedures and escalate if necessary at appropriate time Represent as internal team leader who decides best course of action Negotiate, assess, and monitor project prioritiestimelines for SDTM components Review synopsis andor protocol and provide comments for the Review Committee Provide programming input to CRF and External Data from an SDTM perspective Oversee development of SAS programs to generate SDTM datasets Validation of SDTM datasets to ensure meets regulatory compliance Provide input to the design of the clinical trial database from an SDTM perspective Contribute to the creation, maintenance, and validation of standards for programming tools, outputs and macros Ensure that all programming deliverables are compliant with CDISC Partner with CROs and act as a primary point of contact for SDTM programming activities Provide SDTM programming input into the SOW activities and review associated budget Provide oversight of CROvendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables Receive, process and review datasets, as well as data review reports from CROs Ensure that programming best practices are adhered to by both CRO and Client programmers Participate in studyproject team meetings as a core member and provide technical expertisesupport Other Activities Build networks to achieve influence with other functions and represent as SDTM Programming technical expert.

Leadparticipate in department andor cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes Author, review, approve and train on department procedures including SOPs, Working Practices and Guidance Documents Ensure consistency and adherence to standards and governance within their therapeutic area and the department Routine interface with cross-functional team members during the study startup and execution.

LeadParticipate in programming team meetings when appropriate Represent programming during internal audits as well as Health Authority audits Align with the department and company strategy and model SkillsKnowledge Required BABS degree or equivalent in a relevant scientific discipline with a minimum of 7 plus years of experience supporting clinical trials for regulatory submissions CDISC Experience as a Lead Programmer overseeing the SDTM activities of support programmers as well as CROexternal vendors Strong project management skills good communication skills ability to work in a cross-functional team environment Experience with CDSIC standards including CDASH or SDTMADaM Thorough understanding of clinical data structures, relational database structures, and data exchange with alternate data formats Knowledge of clinical study design.

Detailed knowledge and experience in CRF design, central laboratories, programming databases, query resolution, data validation Demonstrates expertise in the handling and processing of upstream data including multiple data sources, data workflow, eDC, SDTM Demonstrates expertise in providing outputs to meet downstream requirements including ADaM, Data Definition Table, e-submission Proficient in programming languages and demonstrated proficiency in using SAS to produce SDTM datasets In-depth knowledge of FDAICH guidelines, industrytechnology standard practices and good programming practices In depth understanding of regulatory, industry, and technology standards and requirements In depth understanding of statistical terminology, clinical tests, medical terminology, and protocol designs Demonstrate ability to work in a team environment with clinical team members Excellent communication skills, excellent written, verbal, interpersonal and organizational skills Excellent planning and project management skills as well as vendor management Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions.

Qualified candidates should apply online for immediate consideration.PandoLogic.

Keywords: Clinical Programmer, Location: Berkeley Heights, NJ
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