Senior Biostatistician: Regulatory Strategy & Clinical Dev

Evidencia Scientific Search and Selection Limited; United States; Hybrid; USD 120,000 - 190,000; Full time

Job summary

Evidencia Scientific Search and Selection Limited is seeking a Senior Biostatistician to lead statistical strategy across clinical development and regulatory submissions in the US. This role involves advising on trial design, analysis, and interpretation while coordinating SAPs and CDISC SDTM/ADaM workflows.

You will mentor junior staff and collaborate with RWE/HEOR and market access teams, translating complex results into client-ready recommendations in a dynamic consulting environment.

Qualifications

• Hands-on pharmaceutical/biotech clinical-development experience, ideally spanning Phase II/III.
• Experience contributing statistical expertise to major regulatory submissions.
• Strong knowledge of SAPs, TLFs and CDISC-compliant SDTM/ADaM datasets.
• Confident communicator for client-facing advisory role.

Responsibilities

• Provide statistical expertise across clinical development and FDA/EMA regulatory submissions.
• Advise on clinical trial design, analysis strategy and interpretation of results.
• Lead statistical workstreams, including SAPs and regulatory analytical deliverables.
• Work across clinical-trial and real-world evidence datasets.
• Mentor junior colleagues and collaborate with multidisciplinary teams.
• Translate complex statistical findings into clear, actionable client recommendations.

Skills

Biostatistics

Regulatory submissions

Clinical trial design

SAPs

CDISC SDTM/ADaM

Client-facing advisory

Education

Advanced degree in Biostatistics or related field

Job description

Evidencia Scientific Search and Selection Limited is seeking a Senior Biostatistician to lead statistical strategy across clinical development and regulatory submissions in the US. This role involves advising on trial design, analysis, and interpretation while coordinating SAPs and CDISC SDTM/ADaM workflows.

You will mentor junior staff and collaborate with RWE/HEOR and market access teams, translating complex results into client-ready recommendations in a dynamic consulting environment.