Senior Biostatistician

Redbock - an NES Fircroft company; San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Redbock - an NES Fircroft company in San Francisco seeks a lead or supporting statistician for late-phase oncology studies. You will coordinate with cross-functional teams to ensure timely, high-quality deliverables and work on design, analysis and reporting of clinical studies.

PhD or MS in statistics/biostatistics with 5–8 years biotech/pharma experience required, with solid tumor late-stage drug development.

Qualifications

• PhD or MS in statistics/biostatistics with biotech/pharma experience.
• Experience with oncology late-phase studies preferred.
• Familiarity with NDA/BLA submissions desirable.

Responsibilities

• Provide statistical expertise in design, analysis and reporting of clinical studies.
• Partner with cross-functional teams to define analysis scope and timeline.
• Develop statistical analysis plans and detailed analysis specifications.
• QC statistical analyses and perform necessary modeling.
• Collaborate with statistical programmers to ensure analyses follow the plan.
• Coordinate with Data Management and Clinical Operations for robust data collection.
• Contribute to publications ensuring data consistency.
• Prepare statistics sections for Health Authority submissions.
• Represent biostatistics on study teams and support cross-functional decisions.

Skills

Statistical analysis

Cross-functional collaboration

Clinical study design

Education

PhD or MS in statistics/biostatistics

Tools

SAS

R

Job description

This position will serve as a lead or supporting statistician for late-phase oncology studies and will coordinate activities with other functional groups to ensure timely and high-quality deliverables.

Responsibilities

• Provide statistical expertise in the design, analysis and reporting of clinical studies.
• Partner with cross-functional teams to define analysis scope and timeline.
• Develop statistical analysis plans and detailed analysis specifications.
• Conduct and perform QC on statistical analyses, including statistical modeling as needed.
• Collaborate with the statistical programmers to ensure that analyses are 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 the development and review of publications, ensuring data consistency and accuracy.
• Author and review statistics related sections in Health Authority Submissions and Responses ensuring clarity, consistency and accuracy in data presentation.
• Represent biostatistics on study teams and contribute to cross-functional decision-making.

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 a statistician.
• Solid tumor late-stage drug development experience is required.
• Experience with NDA/BLA submission and interaction with Health Authorities is desirable.
• Proficiency in SAS and/or R.

Preferred Skills

• Ability to work independently and within a team.
• Excellent verbal and written communication skills are required.
• Good interpersonal and project management skills are essential.