# Principal Statistician - Rare Diseases Phase III and IV

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/FRA-Remote/Principal-Statistician---Ophthalmology---Fully-remote-in-Europe_25111374?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_fdd7a0c1-816

## Description

Syneos Health is seeking a Principal Statistician to work on rare diseases phase III and IV projects. The successful candidate will serve as a statistical department resource, mentor biostatisticians, and oversee training plans or materials for Biostatistics associates.

Key responsibilities include:

- Directing the activities of other biostatistics personnel on assigned projects to ensure timely completion of high-quality work

- Providing independent review of project work produced by other biostatisticians in the department

- Preparing or overseeing the preparation of Statistical Analysis Plans (SAPs)

- Collaborating with sponsors, if required

- Creating or reviewing programming specifications for analysis datasets, tables, listings, and figures

- Reviewing SAS/R annotated case report forms (CRFs), database design, and other study documentation

- Implementing company objectives and creating alternative solutions to address business and operational challenges

- Interfacing with other departmental project team representatives

- Conducting and participating in verification and quality control of project deliverables

- Managing scheduling and time constraints across multiple projects

- Monitoring progress on study activities against agreed-upon milestones

- Providing statistical programming support as needed

- Participating in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities

- Maintaining well-organized, complete, and up-to-date project documentation

- Displaying willingness to work with others and assisting with projects and initiatives as necessary

Requirements:

- Graduate degree in biostatistics or related discipline

- Extensive experience in clinical trials or an equivalent combination of education and experience

- Proficiency in R programming

- Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research

- Experience across all statistical tasks required to support clinical trials during the lifecycle of the project

- Excellent written and verbal communication skills

- Ability to read, write, speak, and understand English

## Skills

### Required
- R programming
- statistical design
- analysis
- regulatory guidelines
- clinical trials

### Nice to have
- regulatory submissions

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