Clinical Programming (Contractor) Job Listing at Kelly Services in West Chester, PA (Job ID 10137009)

Description

Job Title: Clinical Programming (Contractor)
Location: West Chester, PA
Duration: 2 years with Possible Extensions
Pay: $61.97 - $73.94 (based on experience)

Core Essential Skill Sets:

• Bachelors + 5 years of experience, or 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.
   

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:

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

 

• 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.

Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
• Access to more than 3,000 online training courses through our Kelly Learning Center
• Weekly pay and service bonus plans
• Group-rate insurance options available immediately upon hire*

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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