Senior Principal Biostatistician - CRO Domain

Senior Principal Biostatistician (CRO domain)

Job Purpose:

Serve as a leading role in biostatistics: provide high-level biostatistical support to a wide range of clinical trials as a consultant, both internal and external. The individual also serves as a pivotal role for process and project management.

Location: Remote (WFH)

Experience: 10+ years

Job Responsibilities:

- Develop and lead a Biostatistics group

- Review TLFs, ADaM Specs/data for safety & efficacy, work with programming team to address issues

- Conduct knowledge-sharing sessions and training for the programming team on Statistics

- Communicate with sponsors, vendors, and internal teams

- Develop statistical sections of protocols using Estimands, perform sample size calculations,

- Develop statistical analysis plan and TFL Shells

- Work with Sr. Statisticians at other client locations globally

- Perform exploratory analyses of prior studies or databases to help design new Phase 2 and 3 studies

- Review/write sections of Statistical analysis reports or CSRs

- Provide support on generating required outputs/documents for publications, client presentations, ad hoc requests, etc.

- Help to improve company process and efficiency

- Work with study lead to maintain project timelines & quality per KPI/KQIs