Clinical Programmer - Oncology

ClinChoice · USA

Company

ClinChoice

Location

USA

Type

Full Time

Job Description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Clinical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Summary

The Clinical Programmer Consultant is a delivery focused role who develops and maintains clinical database and analyses clinical data. Being a Clinical Programmer performs data validation and develops algorithm for data management typically using SAS.

Main Job Tasks and Responsibilities:

  • Develop and maintain databases to collect and manage clinical trial data.

    • Perform statistical programming and analysis of clinical trial data using software such as SAS or R.

    • Ensure data accuracy and integrity by conducting data validation and quality checks.

    • Write and validate programs to generate tables listings and figures (TLFs) for clinical trial reports.

    • Create and validate datasets in compliance with CDISC standards (SDTM ADaM).

    • Develop macros and reusable code to streamline data analysis and reporting processes.

    • Ensure compliance with regulatory requirements and guidelines (e.g. FDA EMA) in all programming activities.

    • Prepare and review submission-ready datasets and documentation for regulatory submissions.

    • Collaborate with regulatory teams to address programming-related queries and provide support during inspections.

    • Work closely with biostatisticians data managers and clinical research associates to understand study objectives and requirements.

    • Participate in project meetings and provide input on programming-related aspects of study design and data analysis.

    • Communicate programming issues and solutions to cross-functional teams and stakeholders.

    • Support the design and implementation of clinical trials by providing programming expertise.

    • Assist in the development of case report forms (CRFs) and electronic data capture (EDC) systems.

    • Provide programming support for interim and final analyses of clinical trial data.

    • Stay updated with the latest developments in clinical programming oncology therapeutics and regulatory requirements.

    • Identify opportunities for process improvements and automation in data management and analysis.

Education and Experience:

  • Bachelor’s degree in computer science (CS) statistics or related scientific disciplines with 7-8 yrs. Master’s degree in CS statistics or related disciplines with 7+ yrs.

  • Require strong Oncology TA experience.

  • Excellent programming skills including SAS & R language.

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Contract

Apply Now

Date Posted

07/20/2024

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