Jobs

Description

Does the position allow for the worker to be virtual/remote? Yes

Title: Clinical Programming – Contractor – Analysis and Reporting (ADaM)

Shift Schedule: Regular 40 week working schedule (morning)

Duration: Up to 2 year assignment

Temp to Perm: Not during this time

Core Essential Skill Sets:

• Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
• Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.

Position Summary:

• The Clinical Programming (Contractor) is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
• The clinical programming contractor independently manages completed projects that involve global tasks, or cross functional teams
• The role may require providing inputs to design and analysis, and reporting the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing programming support for publication for our marketed drugs.

Travel Requirements: N/A

Essential Duties & Responsibilities:

• Primarily works at the Study, product / program level
• Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLFs) complying with regulatory requirements, departmental SOPs and work practices.
• Manages and Delivers assignments with good quality and within timelines
• Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLFs.
• Implement programming standards and comply with regulatory requirements among project team members and across all projects; communicate to management on project status and resource gaps.
• Responsible for the standardization of GSD deliverables (TLGs, Datasets) across study projects within an indication/therapeutic area. Provides input on opportunities for process improvement
• Proactively communicates issues impacting programming deliverables with Stat or DM team members.

Position Requirements:

Education Required:

• Bachelor’s Degree/Master’s Degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.

Experience Required:

• Bachelors + 5 year, Masters + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer.
• Proficient knowledge of clinical trials and drug development process, industry standards, statistical concepts used in analysis and submissions of clinical trial data.
• Strong understanding of SDTM, ADaM standards and Implementation guides.
• Demonstrated proficiency in using SAS to produce analysis datasets, TLFs, eSUB components and using other software applications (eg. Pinnacle 21, XML and MS Office)
• Demonstrated ability to work independently and in a team environment.

Experience Preferred:

• Specialized or Technical Knowledge Licenses, Certifications needed:
• Functional Knowledge: Expert level of programming skills and problem resolution in SAS.
• Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspections).
• Have solid knowledge of statistical models used for efficacy data analysis.
• Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas.

Job-Specific Competencies:

• Tackles difficult problems; identifies solutions and recommends action management
• Influences communication toward common understanding and actionable results;
• Good oral and written communication skills.