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 Senior Statistical 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.  

Main Job Tasks and Responsibilities: 

The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities: 

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience:

• Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
• Need to have Oncology TA experience.
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
• Good understanding of the clinical drug development process.
• Strong communication skills and coordination skills.
• Current knowledge of technical and regulatory requirements relevant for the role
• Ability to proactively manage concurrent activities within a project
• Proficient ability to influence relevant stakeholders on programming-related items

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 4,000 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

Job overview:

The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements.

Location: United Kingdom home based or hybrid in our London Office.

Reports to: Associate Director, Statistics and Data Management.

Type: Fixed-term contract for 9 months.

Roles and Responsibilities
(Include but are not limited to):

• Leading and coordinating the programming activities within agreed timelines
• Managing the reporting of studies internally and externally
• Programming outputs as stated in the analysis plan
• Working closely with study team members, mainly with the study statistician
• Reviewing of the Statistical Analysis Plan (SAP) and shells
• Create and review SDTM and ADaM study specifications
• Ensure programs, datasets, outputs are appropriate for regulatory submission
• Perform simulations, data modelling and interim analyses
• Liaise with external vendors on deliverables

Candidate Profile:

• Extensive years experience in statistical programming
• CDISC expertise
• Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R
• Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting
• Experience in performing quality control (QC) checks
• Extensive knowledge in regulatory submission process
• Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
• Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory question
• Ability to solve challenging problems and provide recommendations to mitigate risk
• Good communication skills - both written and verbal
• Team work skills - Including cross-functional and within the Statistics and Data Management Team