Study Data Tabulation Model (SDTM) Programming Lead
Overall Purpose of the Role
• Responsible for the development of SDTM, SDTM +, SDTM annotated CRF and generation of SDTM datasets for various studies across all therapeutic areas.
• Collaborate with client and team to define timelines, identify and resolve issues
Required Skills
RESPONSIBILITIES/AUTHORITIES
• Strictly adhere to 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 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. Expect 80 – 100 % on site time at client site in Woodcliff Lake, NJ
• Annotate CRFs in accordance with 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, 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 Spec review for external data.
• Involved in extensive clinical team contact (Statisticians, Statistical Programmers, Protocol Data Managers (PDMs), etc. 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.
BASIC QUALIFICATIONS:
· Minimum 10 years of relevant programming and drug development experience in CRO, Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials).
· Bachelor’s degree required.
· Expert in CDISC standards and applicability to clinical database design / capture and reporting
· Excellent SAS programming skills, (at least 7 years SAS experience)
· Expert knowledge in clinical trials with 5+ years’ experience working in a clinical project team environment meeting deadlines with quality deliverables
· Expert in integrating SAS with other leading technologies such as XML, Microsoft Office, etc. to support electronic submissions
· Expert 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
Required Experience
RESPONSIBILITIES/AUTHORITIES
• Strictly adhere to 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 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. Expect 80 – 100 % on site time at client site in Woodcliff Lake, NJ
• Annotate CRFs in accordance with 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, 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 Spec review for external data.
• Involved in extensive clinical team contact (Statisticians, Statistical Programmers, Protocol Data Managers (PDMs), etc. 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.
BASIC QUALIFICATIONS:
· Minimum 10 years of relevant programming and drug development experience in CRO, Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials).
· Bachelor’s degree required.
· Expert in CDISC standards and applicability to clinical database design / capture and reporting
· Excellent SAS programming skills, (at least 7 years SAS experience)
· Expert knowledge in clinical trials with 5+ years’ experience working in a clinical project team environment meeting deadlines with quality deliverables
· Expert in integrating SAS with other leading technologies such as XML, Microsoft Office, etc. to support electronic submissions
· Expert 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