Company: Kelly Services
Location: REMOTE, PA
Career Level: Entry Level
Industries: Recruitment Agency, Staffing, Job Board
Description
Job Title: R&D Programmer
Location: Remote
Duration: 13 months with possible extensions.
Shift Schedule: Morning - US time zone 8 hours/day – preferably East Coast
Core essential:
- Minimal Bachelor's degree in any field
- Minimal 5 years experience with Clinical data, SDTM IG, and Pinnacle 21.
Position Summary:
The Clinical Programming Manager is responsible for managing the timely and accurate execution of programming components of clinical trials.
The Manager leads and manages completed projects that involve global tasks, cross functional teams, or outsourcing resources. The role may require providing input to design and analysis, and report the results of clinical trials, including programming rules and mocked T/L/G. In addition, providing all safety claims for new drugs and extension of claims/publication support for our marketed drugs.
Travel Requirements: Limited as job tasks are required
Essential Duties & Responsibilities:
- Provides input for Budget Planning
- Likely to oversee contingent workers and/or vendors; Likely to provide training to others
- Primarily works at the project level
- Delivers assignments with quality and within timelines
- Contributes strategy under moderate supervision
- Provides strong programming support to CDISC based e-submission. Develop, review, and/or perform validation of generic macros.
- Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets
- Has good knowledge and understanding of the statistical models in efficacy data analysis
- Responsible for the standardization of Clinical Programming deliverables within a project
- Extends existing or develops new clinical programming methods to solve complex problems
- Bachelor's Degree/ Master's Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
- Experience Required: Bachelor's + 5 years or Master's + 4 years of professional experience in a pharmaceutical or clinical research setting as a programmer
- Experience in SDTM and ADaM acquainted with CDISC Guidelines and requirements.
Specialized or Technical Knowledge Licenses, Certifications needed
- Advanced level of SAS programming skills. Develop SAS programs and perform QC tasks for integrated analysis.
- Company/Industry Related Knowledge: Intermediate knowledge of government regulations pertaining to drug development in multiple therapeutic areas.
- Contributes to strategy under moderate supervision
- Tackles difficult problems; identifies solutions and recommends action to management
- Influences communication toward common understanding and actionable results; contributes to process and development
- Ability to effectively work in a global environment
- Ability to effectively interact with and influence others without direct reporting relationships
Why Join Us?
Professional Development: Gain hands-on experience with cutting-edge industry standards.
Collaborative Environment: Work with a supportive team committed to high-quality outcomes.
Impactful Work: Ensure our products meet rigorous quality and regulatory standards.
Apply today to take the next step in your career!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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