THB - Biostatistician

Biostatistician - Work from Home

Role:

You will provide statistical consulting and technical support as it relates to the design, statistical analysis, and regulatory submissions of clinical trial studies.

Collaborating with medical and analytics team to produce interim reports and final reports, allowing a comprehensive understanding and interpretation of the clinical study data and outcome.

Duties:

- Protocol development, sample size calculation, protocol and CRF review, and advise data management on database design and critical data

- Coordinate the development of analysis plans, table shells, and programming specifications

- Understand scope of work, estimate the work completed, manage scope, and provide resource forecasts for studies

- Consult on operational/statistical/therapeutic area topics

- Prepare proposal text

- Communicate with clients regarding study protocol

- Act as statistical team lead for single complex studies or groups of studies

- Provide expert statistical input and review of deliverables for validation requirements

- Review of the clinical study report to ensure statistical integrity in the reporting of the results

- Interpret analysis and craft statistical sections of integrated reports

- Provide training and mentoring to team members and department staff

Qualifications:

- You should possess a MSc or PhD in Biostatistics or Statistics, with relevant experience.

- Work experience in statistics

- Ability to communicate and explain statistics

- Exhibit routine and complex analytical skills

- A focus on quality and accuracy

- A good understanding of Good Clinical Practice and ICH guidelines

- Experience in programming in R Studio, SPSS, SAS

- Ability to independently lead

- Take initiative and work with integrity

- Ability to establish and maintain effective working relationships