Clinical Biostatistician – Oncology (Early Phase)

Unicon Pharma Inc; United States; On-site; USD 120,000 - 190,000; Full time

Job summary

Unicon Pharma Inc. seeks a lead or contributing statistician to support early-phase oncology studies and coordinate activities with cross-functional groups to ensure timely, high-quality deliverables.

Responsibilities include developing SAPs and analysis specifications, conducting analyses with QC, and collaborating with data management and clinical operations to ensure robust data collection and accurate presentations for publications and regulatory documents.

Qualifications

• PhD or MS in statistics/biostatistics required.
• Experience in biotech/pharmaceutical industry as statistician is essential.
• Solid tumor drug development experience required.
• Early development clinical studies experience is a plus.
• Excellent verbal and written communication skills required.
• Ability to work independently and in a team.

Responsibilities

• Lead or support statistician on early-phase oncology studies.
• Coordinate with other functional groups to ensure timely deliverables.
• Provide statistical expertise for design, analysis, and reporting of clinical studies.
• Develop statistical analysis plans and analysis specifications.
• QC statistical analyses and collaborate with statistical programmers.
• Support robust CRF and database development with data management and clinical operations.
• Contribute to development and review of publications and regulatory documents.

Skills

Statistical analysis

Clinical study design

Data interpretation

Team collaboration

Communication

Education

PhD in statistics/biostatistics

MS in statistics/biostatistics

Tools

SAS

R

Job description

• This position is to serve as a lead or supporting statistician for early-phase oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables.
• Provide statistical expertise for design, analysis and reporting of clinical studies
• Develop statistical analysis plans and analysis specifications.
• Conduct and/or perform QC on statistical analyses, including statistical modeling, as needed
• Collaborate with the statistical programmer team to ensure that analysis is conducted per statistical plan and specifications.
• Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.
• Contribute to development and review of publications and regulatory documents, and ensure consistency and accuracy in data presentation
• Represent biostatistics on study teams.

Required Skills, Experience and Education:

• Ph.D. or M.S. in statistics or biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in the biotech/pharmaceutical industry as statistician.
• Solid tumor drug development experience is required.
• Experience with early development clinical studies is desirable.
• Ability to work independently and within a team.
• Excellent verbal and written communication skills are required.
• Good interpersonal and project management skills are essential.