Principal Clinical Biostatistician

Start Date:

ASAP Location:

EU / UK / Ukraine / South Africa (or ability to overlap minimum 4 hours with EST) Employment Type:

Full-Time / Contract (to be specified)

We are seeking a highly experienced

Principal Clinical Biostatistician

to provide strategic and operational statistical leadership across oncology clinical development programs. This role requires strong technical expertise, regulatory insight, and the ability to function as a study lead statistician on complex clinical trials, including integrated analyses. The ideal candidate will have deep oncology experience, strong CDISC knowledge, and proven expertise in SAP development and cross-functional collaboration within global clinical teams. Key Responsibilities Serve as

Lead Biostatistician

for one or more clinical studies (Phase I–III), primarily in Oncology. Lead development, authoring, and review of

Statistical Analysis Plans (SAPs) . Provide statistical input into protocol development, study design, and sample size determination. Review and provide statistical oversight for

eCRFs , ensuring alignment with study objectives and endpoints. Oversee and review CDISC-compliant datasets (SDTM/ADaM) and statistical outputs. Lead or contribute to

Integrated Summary of Safety (ISS)

and

Integrated Summary of Efficacy (ISE)

analyses. Collaborate closely with Clinical Development, Data Management, Programming, Regulatory Affairs, and Medical Writing teams. Provide statistical input for regulatory submissions and support health authority interactions, as required. Ensure adherence to regulatory standards and industry best practices.

Required Qualifications Minimum

5+ years of experience

in clinical trial biostatistics. At least

2+ years of recent Oncology therapeutic area experience

(strongly preferred). Demonstrated experience working as a

Study Lead Statistician . Strong hands-on experience with: CDISC standards (SDTM, ADaM) SAP development and review eCRF design and review Integrated/pooled analyses (e.g., ISS/ISE) Solid understanding of global regulatory requirements (FDA, EMA, ICH). Proficiency in statistical software such as SAS (R knowledge is a plus). Excellent written and verbal communication skills. Proven ability to collaborate effectively within global, cross-functional teams.

Preferred Attributes Experience supporting regulatory submissions (NDA/BLA/MAA). Prior experience in complex oncology trials (e.g., survival analysis, time-to-event endpoints). Strong problem-solving and strategic thinking capabilities. Ability to work independently in a remote/global environment.

Working Requirements Must be based in

EU, UK, Ukraine, or South Africa , OR Willing and able to provide at least

4 hours daily overlap with EST .