Senior Scientist, SDTM - Statistical Programming (Hybrid PA/NJ)

Job Description

The Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the Study Data Tabulation Model (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 Case Report Tabulation (SDTM) study data deliverables (SDTM dataset, Define Extensible Markup Language (XML), Study Data Reviewer Guide (SDRG), Annotated Case Report Form (aCRF)), collaborating and consulting 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 standard deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders.
 

Primary Responsibilities

• Supporting project teams in creating Study Data Tabulation Model (SDTM) deliverables for Analysis and Reporting (A&R) and submission

• Supporting project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise

• Up-versioning activities to specific versions of (SDTM) Study Data Tabulation Model

• Develop Statistical Analysis System (SAS) programs, standards macros to enhance the process

• Collaborate effectively with project team members

• Participation in industry teams and conferences on best practices

• Membership on departmental strategic initiative project teams

Education Minimum Requirements:

• Bachelor of Arts or Science (BA/BS) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering with a minimum of five (5) years SAS programming experience in a clinical trial environment.

Required Experience and Skills:

• Experience with study data standards CDISC (SDTM)

• Experience in SAS and clinical programming

• Knowledge and experience in developing analysis and reporting deliverables for Research & Development projects(data, analysis, tables, graphics, listings)

• Excellent communication and negotiation skills / excellent teamwork and collaboration

• Excellent written and verbal, and presentation skills; effective technical writing, able to convert complex ideas and information into simple readable form

• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

• Solid project management skills

• Demonstrated success in the assurance of deliverable quality and process compliance

• Familiarity with statistical and clinical data management concepts

Preferred Experience and Skills

• Strong working knowledge of reporting processes Standard Operating Procedure (SOP) and software development life-cycle (SDLC)

• Experience ensuring consistency across protocols and projects

• Strategic thinking ability to turn strategy into tactical activities

• Ability and interest to work across cultures and geographies

• Ability to complete statistical deliverables using global outsource partner programming staff

• Experience developing and managing a project plan using Microsoft Project or similar package

• Active in industry forums and professional societies

• Experience in process improvement

• Knowledge of Metadata Repositories (MDR)

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