Senior Statistical Programmer
Quotient Sciences
Senior Statistical Programmer
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,300 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Data Sciences at Quotient comprises over 100 staff and provides an expert service in the data management, pharmacokinetics, programming, statistical analysis and reporting of early Phase clinical studies.
Due to our continued growth and success we have an excellent career opportunity for a talented Programmer to join our Statistical Programming department and further your career. You will be involved in the challenging environment of early phase clinical studies and play a key role in the expansion and continuous development of our statistical programming services.
Main tasks and responsibilities include:
- Generate SDTM/ADaM dataset specfications
- Programming SDTM/ADaM datasets including validation
- Programming listings, tables and figures
- Writing Data Transfer Specifications
- Programming files and datasets for issue to the Lead PK or Lead Statistician
- Define-xml packages including Reviewers Guides and conformance reports
- Peer review of some or all of the above
- Review and programming input into key study documents e.g., Data Management Plans, Reporting and Analysis Plans, Gantts, etc.
Dependent on your development, our career pathway allows you to expand your role over time, and progress to more senior roles and tasks. Training will be provided to help your further your programming skills and achieve a Lead Statistical Programmer role within Data Sciences project teams. Experienced candidates may also become involved in staff training/mentoring, sponsor contact and where relevant, discussions relating to use of sponsor standards/procedures.
Early Phase studies present particular programming challenges due to their complexity (often with multiple study parts), PK data, interim deliverables, protocol changes and the urgent requirement from sponsors for their key results; you will be expected to be flexible and creative in your programming skills.
The Candidate
The successful candidate will have a degree and SAS programming experience, ideally in an early phase GCP environment. Experience of programming clinical data, SDTM/ADaM datasets, listings, tables, figures and/or working with PK domains would be an advantage. Prior experience of training other clinical SAS programmers, define-xml, Pinnacle21 software or experience as a Lead Statistical Programmer are required for more senior roles.
Other skills and experience required:
- Good organisational and presentation skills
- Ability to work to tight deadlines whilst maintaining quality standards
- Attention to detail and the ability to multitask
- Effective oral and written communication skills
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When applying for a position with Quotient Sciences you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient family and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Other details
- Pay Type Salary
- Travel Required No