# Principal Statistician - Early Phase

**Company**: Syneos Health
**Location**: GBR-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GBR-Remote/Principal-Statistician---Early-Phase---Fully-home-based--remote-anywhere-in-Europe--Sponsor-Dedicated---Program-Project-Leader_25113580?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_edd38b7b-83d

## Description

Syneos Health is seeking a Principal Statistician - Early Phase to lead the development and execution of clinical development plans, including defining Go/No Go frameworks. The successful candidate will use simulations and statistical strategies to inform and influence trial design decisions, serve as a statistical department resource, mentor biostatisticians, and oversee training plans and materials. They will direct the activities of other biostatistics personnel, provide independent review of project work, and prepare or oversee the preparation of Statistical Analysis Plans (SAPs).

Responsibilities:

- Leads the development and execution of clinical development plans, including defining Go/No Go frameworks.

- Uses simulations and statistical strategies to inform and influence trial design decisions.

- Serves as a statistical department resource, mentors biostatisticians, and oversees training plans and materials.

- Directs the activities of other biostatistics personnel on assigned projects.

- Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR.

- Prepares or oversees the preparation of Statistical Analysis Plans (SAPs).

- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.

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

- Implements company objectives and creates alternative solutions to address business and operational challenges.

- Interfaces with other departmental project team representatives.

- Conducts and participates in verification and quality control of project deliverables.

- May lead complex or multiple projects, attend regulatory agency meetings, or respond to questions.

- Manages scheduling and time constraints across multiple projects.

- Monitors progress on study activities against agreed-upon milestones.

- Provides statistical programming support as needed.

- May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities.

- Maintains well-organized, complete, and up-to-date project documentation.

- Displays willingness to work with others and assists with projects and initiatives as necessary.

- Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.

Qualification Requirements:

- Master's degree in biostatistics or related discipline.

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

- Program/project level leadership and contributions to clinical development strategy.

- Proficiency in R programming.

- Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques.

- 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
- biostatistics
- R programming
- statistical design
- analysis
- regulatory guidelines
- programming techniques

### Nice to have
- regulatory submissions
- Data Safety Monitoring Board (DSMB)
- Data Monitoring Committee (DMC)

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GBR-Remote/Principal-Statistician---Early-Phase---Fully-home-based--remote-anywhere-in-Europe--Sponsor-Dedicated---Program-Project-Leader_25113580?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)