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- Tasks: Join our Biometrics Department as a Senior Statistical Programmer, ensuring reliable clinical trial data.
- Company: Simbec-Orion is a dynamic CRO focused on improving patients' lives through innovative clinical solutions.
- Benefits: Enjoy flexible work options, professional development opportunities, and a supportive team culture.
- Why this job: Make a real impact in medicine while collaborating with experts in a fast-paced environment.
- Qualifications: Experience in statistical programming, particularly with SAS, and knowledge of clinical development processes required.
- Other info: Opportunity for mentorship and involvement in process improvement initiatives.
The predicted salary is between 36000 - 60000 £ per year.
Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine. We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.
We are looking for a Senior Statistical Programmer to join our Biometrics Department where you will provide programming and statistical support to allocated studies and will be responsible for ensuring that the clinical trial data is reliable and accurate. You will work closely with the Lead Statistician, SAS Programming Study Statistician and will communicate programming related study issues. You will contribute towards technical leadership within the SAS programming team, ensuring clinical trials are conducted such that subjects’ rights, safety and well-being are protected and is completed within the agreed project timelines.
Key Accountabilities
- Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis.
- Liaises with Data Management and statistician to ensure the data needed for statistical output from CRF data is available.
- Manages the flow of work for allocated studies to ensure the scope of work, budget and timelines for all study-related activities are adhered to and flags potential changes in scope, database and programming issues to internal and external study teams and suggests resolutions.
- Acts as the Statistical Programming point of contact for allocated studies and supports at Sponsor meetings.
- Attends study team meetings throughout the life of the study to communicate issues that may affect the study.
- Provides solutions to issues that arise during the conduct and analysis of the study.
- Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and updating SOPs.
- Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc.
- Provides in-house training, technical support and mentoring for colleagues.
- Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert.
- Performs ad hoc programming tasks to assist the Head of Statistics with data review.
Skills Required
ESSENTIAL
- Previous experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation.
- Significant SAS programming experience.
- Experience of working in multi-disciplinary teams.
- Comprehensive knowledge of the Clinical Development process and its critical paths.
DESIRABLE
- Master’s Degree qualified in Statistics or overseas equivalent.
- Previous experience of leading or managing a SAS Programming Team.
- Experience of Statistical Programming across Phase 1/II/III Clinical Trials.
- Awareness of Global regulatory environment.
- Experience of a wide breadth of therapeutic areas.
- Knowledge of CDISC standards.
- Experience in define-XML production and FDA documentation requirement.
Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team. With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.
Senior Statistical Programmer employer: Simbec-Orion Group
Contact Detail:
Simbec-Orion Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Statistical Programmer
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines such as GCP, MHRA, and CDISC standards. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards in clinical trials.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in statistical programming. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to process improvements in previous roles. Highlighting your experience in leading initiatives can set you apart as a candidate who adds value beyond just technical skills.
✨Tip Number 4
Be ready to showcase your SAS programming expertise during the interview. Consider preparing a portfolio of your past projects or analyses that demonstrate your ability to produce reliable datasets and statistical outputs.
We think you need these skills to ace Senior Statistical Programmer
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Statistical Programmer position. Familiarise yourself with key terms like SAS programming, clinical trial processes, and regulatory guidelines.
Tailor Your CV: Customise your CV to highlight relevant experience in statistical programming, particularly within the pharmaceutical industry or clinical research. Emphasise your SAS programming skills and any leadership roles you've held.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving patients' lives through your work. Mention specific experiences that demonstrate your ability to manage studies, liaise with teams, and contribute to process improvements.
Highlight Relevant Skills: In your application, clearly outline your knowledge of clinical development processes, CDISC standards, and any experience with regulatory environments. This will show that you are well-prepared for the challenges of the role.
How to prepare for a job interview at Simbec-Orion Group
✨Showcase Your SAS Expertise
Make sure to highlight your significant experience with SAS programming during the interview. Be prepared to discuss specific projects where you used SAS to produce datasets, tables, and statistical analyses, as this is crucial for the role.
✨Demonstrate Team Collaboration
Since the role involves working closely with statisticians and data management teams, share examples of how you've successfully collaborated in multi-disciplinary teams. This will show your ability to communicate effectively and manage study-related issues.
✨Understand Regulatory Requirements
Familiarise yourself with relevant regulatory guidance such as GCP, MHRA, and CDISC standards. Being able to discuss these regulations and how they impact clinical trials will demonstrate your knowledge and commitment to compliance.
✨Prepare for Problem-Solving Questions
Expect questions about how you've handled challenges in previous studies. Prepare specific examples where you provided solutions to programming or data issues, as this will showcase your critical thinking and leadership skills.
