Job Description
Position Summary :
The Statistical Programming Contractor 3 is responsible for providing comprehensive programming support, including managing the timely and accurate execution of programming components of clinical trials.
The statistical 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 :
1. Primarily works at the study, product / program level
2. Provides comprehensive programming support, including development of programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices.
3. Manages and Delivers assignments with good quality and within timelines
4. 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 TLGs.
5. 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.
6. Responsible for the standardization of GSD deliverables (datasets and associated TLGs) across study projects within an indication / therapeutic area. Provides input on opportunities for process improvement
7. 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 :
Experience Preferred :
Specialized or Technical Knowledge Licenses, Certifications needed :
Functional Knowledge :
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 :
1 Tackles difficult problems; identifies solutions and recommends action management
3. Good oral and written communication skills.
Pay ranges between $65-71.80 / hr based on experience
Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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Programmer • Boston, MA, United States