IT Elite Inc is looking for Standards Programmers to work on long term client projects.

W-2 / Remote / Full time opportunity.
5-8+ years experience is required.

Job Responsibilities:

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.
• Assesses the quality and consistency of analysis data and performs cross-study analyses.
• Uses internal macros or writes SASฎ macros to automate study deliverables.
• Works as a Lead Biostatistician or Lead Programmer for multiple Phase 1-4 studies.
• Assists in submissions of electronic data (e.g., SASฎ data sets) to regulatory agencies.
• Independently develops analysis shells, specification & programs.
• Identifies potential issues in study documentation and proposes solutions.
• Contributes to strategic initiatives.
• Assist with study and systems audits by GSI Compliance Group and external bodies, and respond to audit questions and findings.
• Promote and communicate awareness of programming and the role of the Biometrics department (internal/external; scientific/process)
• Excellent verbal and written communication skills and interpersonal skills are required.
• Has thorough knowledge of clinical trial study design and electronic data submission requirements. Must be able to work independently on multiple concurrent projects.

Key Responsibilities to these positions:

• Contributes to Analysis Planning and Reporting standardization activities and departmental initiatives.
• Works with-in the Global Clinical Data Standards team in collaboration with each data state: Data Collection, SDTM and ADaM on Analysis Planning and Reporting standardization activities and departmental initiatives.
• Collaborate cross-functionally with Macro team, Biostatistics, Statistical Programming, Medical Writing, and Clinical Development as needed.
• Successfully interacts within Clinical Data Science, with Clinical Development, Patient Safety and Regulatory Affairs groups on a frequent basis.
• Expert knowledge of analysis planning and reporting standards – which includes the Statistical Analysis Plan (SAP) template, Tables, Figures, and Listings (TFLs) shells and submission requirements.
• Develop, review, maintain, and align new and current Sponsor analysis planning and reporting standards to Regulatory Agency submission requirements, CDISC TAUGS, and CDISC standards.
• Review Data Collection, SDTM and ADaM standards for updates and impacts on current Standard TFL shells.
• Serve as a subject matter expert on Sponsor’s reporting standards and related tools/applications, such as STARS. Maintains requirements and documentations for these tools/applications.
• Develop, review, and maintain documentation and training related to analysis planning and reporting standards processes and tools
• Biostatisticians and Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Sponsor's regulatory, scientific and business objectives.

If your skills match the above requirement, Please forward your resume as a word attachment with salary requirement and contact information.