Company:
Katalyst Healthcares & Life Sciences
Location: South Plainfield
Closing Date: 28/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
The Senior Study Data Tabulation Model (SDTM) Statistical Programmer provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects.
Accountability predominantly includes creation and validation of study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.
The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance and data fitness.
The position is a key collaborator with statistical programming, statistics, global data management and other project stakeholders.
Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
Up-versioning activities to specific versions of SDTM.
Partner effectively with project team members.
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project teams.
Requirements:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 6 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 4 years SAS programming experience in a clinical trial environment.
Strong SAS programming skills with demonstrated experience in macro development.
Demonstrated experience in CDSIC standards with strong command in SDTM.
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings). Accountable for tasks at project level; ability to partner with key stakeholders.
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
Demonstrated success in the assurance of deliverable quality and process compliance. Excels in technical writing, able to convert complex ideas and information into simple readable form.
Solid project management skills and effective written, oral, and presentation skills.
Familiarity with data collection and clinical data management concepts and application in SDTM.
Strategic thinking - ability to turn strategy into tactical activities.
Ability to anticipate stakeholder requirements
Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).
Assuring consistency across protocols and projects.
Ability and interest to work across cultures and geographies. Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
Developing and managing a project plan using Microsoft Project or similar package.
Active in professional societies.
Process improvement.
Knowledge of Meta Data Repositories.
The Senior Study Data Tabulation Model (SDTM) Statistical Programmer provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects.
Accountability predominantly includes creation and validation of study data standard deliverables (SDTM dataset, Define.XML, SDRG, aCRF), collaborating with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.
The incumbent will be responsible for continuous improvement of our electronic submission process for study data standards deliverables and providing tools and templates to assist delivery focusing on traceability, quality assurance, data conformance and data fitness.
The position is a key collaborator with statistical programming, statistics, global data management and other project stakeholders.
Assist project teams in creating SDTM deliverables for Analysis and Reporting (A&R) and submission.
Support project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise.
Up-versioning activities to specific versions of SDTM.
Partner effectively with project team members.
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project teams.
Requirements:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 6 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with at least 4 years SAS programming experience in a clinical trial environment.
Strong SAS programming skills with demonstrated experience in macro development.
Demonstrated experience in CDSIC standards with strong command in SDTM.
Effective interpersonal skills and ability to negotiate and collaborate effectively.
Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings). Accountable for tasks at project level; ability to partner with key stakeholders.
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
Knowledge of submission standards CDISC SDTM, Define.XML, SDRG, aCRF.
Demonstrated success in the assurance of deliverable quality and process compliance. Excels in technical writing, able to convert complex ideas and information into simple readable form.
Solid project management skills and effective written, oral, and presentation skills.
Familiarity with data collection and clinical data management concepts and application in SDTM.
Strategic thinking - ability to turn strategy into tactical activities.
Ability to anticipate stakeholder requirements
Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC).
Assuring consistency across protocols and projects.
Ability and interest to work across cultures and geographies. Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
Developing and managing a project plan using Microsoft Project or similar package.
Active in professional societies.
Process improvement.
Knowledge of Meta Data Repositories.
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