# Principal Statistician Oncology with Submission Experience

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/GBR-Remote/Principal-Statistician-Oncology-with-Submission-Experience_25108916?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6221e84a-1e1

## Description

We are seeking a Principal Statistician Oncology with Submission Experience to join our Clinical Solutions team. As a Principal Statistician, you will serve as a statistical department resource, mentor biostatisticians, and oversee or develop training plans or materials for Biostatistics associates.

Responsibilities:

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

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

- Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures

- Collaborates with sponsor, if required

- 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 to ensure protocol criteria are met

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

- Interfaces with other departmental project team representatives as biostatistics representative on project teams

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

- May lead complex or multiple projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to questions

- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and proactively communicates to biostatistics management any difficulties with meeting these timelines

- Monitors progress on study activities against agreed-upon milestones and ensures the study timelines for project deliverables are met

- Provides statistical programming support as needed

- Participates in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician

- Maintains well-organized, complete, and up-to-date project documentation and verification/quality control documents and programs

- Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business

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

Qualification Requirements:

- Graduate degree in biostatistics or related discipline

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

- Proficiency in programming

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

- Excellent written and verbal communication skills

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

Benefits:

- Career development and progression opportunities

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Inclusive culture

## Skills

### Required
- biostatistics
- clinical trials
- statistical analysis
- programming
- regulatory guidelines

### 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-Oncology-with-Submission-Experience_25108916?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)