Stats, Stats Programming, PK and Medical Writing - Clinical Programmer II
Edinburgh, UK
Job Description
Quotient Sciences: Molecule to Cure. Fast.
Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing.
Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times.
Why join us
Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.
The Role
We’re looking for a Clinical Programmer II to join our Clinical Programming team within the Data Sciences department. This is a hybrid role based at our Edinburgh site.
In this role, you will prepare data transfer and dataset specifications, review Data Management Plans (DMPs), support eSource documentation, and undertake end‑to‑end programming and validation of SDTM datasets. You will also perform SAS consistency checks, data reconciliation, and non‑define dataset transfers.
You will ensure all activities are completed to the highest quality standards and in accordance with clinical protocols, SOPs, CDISC guidelines, regulatory requirements, and established timelines.
What You’ll Do
* Lead clinical programming activities for assigned studies, attending Data Sciences KOM and Pre‑Lock meetings to provide programming input and study updates.
* Review Data Management Plans (DMPs) and CRFs
* Prepare external data transfer specifications
* Prepare SDTM dataset specifications, programming and double‑programming SDTM datasets, and carrying out validation for safety data; provide programming and validation support for non‑safety SDTM datasets,
* Receive, load, and reconcile external data, carrying out both routine and non‑routine SAS consistency checks.
* Maintain accurate, organised, and audit‑ready study documentation in line with Quotient processes.
* Deliver programming activities within agreed timelines while keeping line management informed of study progress, risks, and issues.
* Monitor study scope and escalate out‑of‑scope sponsor requests to senior management.
* Ensure all work adheres to departmental SOPs, safety procedures, and regulatory requirements.
* Work collaboratively across teams, supporting business needs by undertaking additional tasks where required and contributing flexibly to department operations.
* Participate in overtime when necessary to support the smooth running of the department.
About You
* Degree in a scientific or numerate discipline
* Experience in clinical programming or a related field
* Strong SAS programming skills, including complex programming
* Excellent communication, attention to detail and problem‑solving skills
* Proficient with Word, Excel and Email
* Knowledge of clinical data, ICH/GCP and CDISC
* Able to prioritise, work independently, and thrive in a fast‑paced environment
The closing date for applications is 22nd April 2026.
Application Requirements
When applying for a position with Quotient Sciences to be able to work in our organization 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 workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
#J-18808-Ljbffr