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: 7-9 years

Qualifications: Master's Degree in Statistics

Key Accountabilities:

- Lead study as study statistician, assign the tasks to team members (statistician & programmers), monitor timeline & quality of the work.

- Interact with clients as the key point of contact about programming and Statistical issues.

- Develop/review statistical analysis plan, TFL Shells, and randomization schedule.

- Work with DM for review of eCRFs, Critical variables lists, etc.

- Support in the creation of statistical analysis reports, Clinical Study Report, if needed

- Produce/validate Analysis Datasets and TFLs. Check TFLs for consistency, quality check the derived dataset/ADaM/ADS specifications, programming specifications/Shells, and other process-supporting documents.

- Provide project performance evaluation inputs for the team members when requested.

- Mentor & train stat analysts and junior statisticians for technical issues.

- Learn and adhere to internal and external SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements.

- Enhance technical skills including SAS programming, statistics, and clinical trials through self-learning, coaching, internal training, external training, and on-the-job training.

- Effective English verbal and written communication skills

- Must have worked in Phase 3 project.