Senior / Principal Biostatistician
Oncology-Focused
Global Biopharma
Are you a biostatistician who wants to be close to the science — not just the data?
We’re working with a specialist, commercially active diagnostics company with a strong oncology focus and a growing clinical pipeline. This is a hands-on study statistician role where your work reaches all the way from trial design to regulatory filing. You won’t be one layer removed from the decision-making. You’ll be in the room.
The Role
Reporting to the Director of Biometrics, you’ll serve as study statistician across assigned oncology clinical programs — owning the statistical work end-to-end. That means contributing to protocol design, authoring and reviewing SAPs, supporting CDISC-compliant data standards (SDTM/ADaM), overseeing CRO/vendor outputs, and contributing directly to NDA/MAA submissions.
This is a role for someone who wants regulatory depth and scientific ownership, not just analytical throughput.
What You’ll Be Doing
- Acting as lead statistician on assigned oncology studies within a cross-functional project team
- Authoring and reviewing Statistical Analysis Plans
- Supporting trial design, protocol development, and database setup documentation
- Overseeing biometrics vendors — timelines, deliverables, quality
- Working with CDISC standards: SDTM, ADaM, define.xml, Pinnacle21
- Contributing to NDA/MAA submissions and clinical study reports
- Collaborating closely with Medical, Clinical Operations, Imaging, and Regulatory Affairs teams
What We’re Looking For
- BSc in a mathematical or scientific discipline; MSc or PhD in Statistics strongly preferred
- Solid experience applying statistical methods in clinical trials
- Hands-on experience with SAS and/or R in a drug development context
- In-depth knowledge of CDISC standards and regulatory submission requirements
- Experience working with external vendors in a CRO or sponsor environment
- Oncology or diagnostic imaging experience is a genuine advantage
- Strong communicator who is comfortable in a cross-functional, matrixed setting
Why This Role?
This is not a large-pharma seat where your SAP sits in a queue for six weeks. It’s a focused, science-first environment where biostatistics has a visible seat at the table, your contributions are traceable to outcomes, and the regulatory complexity is genuinely interesting — particularly around imaging endpoints in oncology.
The company is well-funded, pipeline-active, and backed by a major international diagnostics group. You get the intellectual environment of a specialist organisation with the stability of an established parent.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
…