Biostatistical Programmer (m/f/d)
About the Role:
A leading global pharmaceutical company is seeking an experienced freelance biostatistical programmer to support a pivotal Phase 3 clinical trial. This is a contract-based opportunity ideal for professionals with strong statistical programming skills and prior submission experience.
Key Responsibilities:
- Support the integration of new trial data into an existing pooled analysis dataset.
- Create and validate statistical outputs including tables, figures, and listings (TFLs).
- Perform quality control (QC) of programming documentation and outputs.
- Develop and maintain ADaM datasets in compliance with CDISC standards.
- Collaborate with cross-functional teams to ensure readiness for regulatory submission.
Required Skills & Experience:
- Proven experience in Phase 3 clinical trials, ideally within large pharma or CRO environments.
- 5-10 years experience working with a pharmaceutical company.
- Proficiency in SAS and R for statistical programming.
- Strong working knowledge of ADaM datasets and CDISC standards.
- Experience with regulatory submissions (e.g., FDA, EMA).
- Ability to work independently and manage timelines effectively.
Preferred Qualifications:
- Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a related field preferred.
- Familiarity with clinical trial data standards and documentation best practices.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.Â
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.