Clinical Data Programmer

Edinburgh - UK

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

For 75years Charles River employees have worked together to assist in the discovery development and safe manufacture of new drug therapies. When you join our family you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences finance IT sales or another area your skills will play an important role in the work we return well help you build a career that you can feel passionate about.

Job Summary

Do you have expertise in Clinical Data Programming

Have you got the desire to improve health and lives

Charles River Laboratories are looking to recruit for aClinical Data Programmer as part of their Clinical Support Services function on a full time permanent basis. Working remotely (within the EU/UK only) youll be a highly skilled team member accountable for programmatically extracting transforming and reporting any complexity of test and production clinical datasets in an accurate and timely fashion in accordance with applicable requirements and guidelines.

What youll be doing:

Utilize code to produce production clinical datasets by working with team members in the operation of established systems and / or standardized code.

Develop reusable code according to requirements specifications and following SOPs to produce clinical datasets for User Acceptance Testing (dummy and/or live data). Capable of integrating multiple complex inputs into the desired output.

Prepare as needed full SDTM and/or ADaM datasets

Review data and code to verify integrity and consistency for completeness accuracy and suitability including data adherence to protocol data coding integrity reliability of collection and interpretation.

Lead in troubleshooting assigned generic code application code or specific study work. Ensure clinical datasets are prepared in accordance with study documentation such as a Data Transfer Agreement and with applicable regulations.

Maintain organized complete and up-to-date study documentation testing and quality control documents and programs in compliance with company standards and regulatory guidelines.

Review Data Transfer Agreements and/or Specifications.

Keeps internal and external stakeholders informed of strategy plans and changes as needed to provide quality products and services.

Responsible for assigned study schedules and for coordinating internal and external resources.

Support application development and study code standardization.

Manage complex workload from assigned study projects with priority clients and expedited timelines.

Mentor peers and junior staff in support of business needs and team development.

Design develop implement support and administer validated and unvalidated systems that produce custom tables and graphs including statistical analyses and systems that promote business intelligence across the organization.

Research review and advise on new technology that may be used within the department. Draft and/or update relevant SOPs and other procedural documents.

Able to function as team lead and support the Supervisor as needed with scheduling and other administrative activities.

Perform all other related duties as assigned.

Profile and Requirements

Bachelors Degree (B.S./B.A.); scientific discipline preferred.

Significant experience with SAS; regulated environment or clinical research organization experience preferred

Demonstrated experience in SAS is required; including SAS macros arrays SQL SAS Graph and; knowledge with different output formats (e.g. .rtf .xml .xpt).

Proficiency with a programming language other than SAS (e.g. .NET VBA) a plus.

Familiarity with the System Development Lifecycle (SDLC) a plus.

Demonstrated excellent organizational skills.

Basic familiarity with Microsoft Office Suite.

Computer skills commensurate with Essential Functions including the ability to learn a validated system.

Ability to work extended hours beyond normal work schedule to include but not limited to evenings weekends extended shifts and/or extra shifts sometimes on short notice.

Ability to work under specific time constraints.

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services both Good Laboratory Practice (GLP) and non-GLP to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model which reduces their costs enhances their productivity and effectiveness to increase speed to market.

With over 20000 employees within 110 facilities in over 20 countries around the globe we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies biotechnology companies government agencies and hospitals and academic institutions around the world.

At Charles River we are passionate about our role in improving the quality of peoples lives. Our mission our excellent science and our strong sense of purpose guide us in all that we do and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.

At Charles River Laboratories we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

Job Summary

Do you have expertise in Clinical Data Programming

Have you got the desire to improve health and lives

What youll be doing:

Utilize code to produce production clinical datasets by working with team members in the operation of established systems and / or standardized code.

Prepare as needed full SDTM and/or ADaM datasets

Maintain organized complete and up-to-date study documentation testing and quality control documents and programs in compliance with company standards and regulatory guidelines.

Review Data Transfer Agreements and/or Specifications.

Keeps internal and external stakeholders informed of strategy plans and changes as needed to provide quality products and services.

Responsible for assigned study schedules and for coordinating internal and external resources.

Support application development and study code standardization.

Manage complex workload from assigned study projects with priority clients and expedited timelines.

Mentor peers and junior staff in support of business needs and team development.

Research review and advise on new technology that may be used within the department. Draft and/or update relevant SOPs and other procedural documents.

Able to function as team lead and support the Supervisor as needed with scheduling and other administrative activities.

Perform all other related duties as assigned.

Profile and Requirements

Bachelors Degree (B.S./B.A.); scientific discipline preferred.

Significant experience with SAS; regulated environment or clinical research organization experience preferred

Demonstrated experience in SAS is required; including SAS macros arrays SQL SAS Graph and; knowledge with different output formats (e.g. .rtf .xml .xpt).

Proficiency with a programming language other than SAS (e.g. .NET VBA) a plus.

Familiarity with the System Development Lifecycle (SDLC) a plus.

Demonstrated excellent organizational skills.

Basic familiarity with Microsoft Office Suite.

Computer skills commensurate with Essential Functions including the ability to learn a validated system.

Ability to work extended hours beyond normal work schedule to include but not limited to evenings weekends extended shifts and/or extra shifts sometimes on short notice.

Ability to work under specific time constraints.

At Charles River Laboratories we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.