Senior Biostatistician

Syneos Health; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled biostatistician to provide comprehensive support across various statistical tasks in clinical projects. This role involves preparing detailed Statistical Analysis Plans, collaborating with sponsors, and ensuring high-quality project deliverables. With a focus on regulatory guidelines and statistical programming, you will coordinate activities, mentor team members, and contribute to business development efforts. If you possess a graduate degree in biostatistics and have experience with SAS and JMP, this is a fantastic opportunity to make a significant impact in the field.

Qualifications

• Graduate degree in biostatistics or related discipline required.
• 3+ years of hands-on CMC experience with JMP for statistical analysis.

Responsibilities

• Provides support across all assigned statistical tasks during project lifecycle.
• Prepares Statistical Analysis Plans and collaborates with sponsors as needed.

Skills

Statistical Analysis

SAS Programming

R Programming

Quality by Design (QbD)

Design of Experiments (DoE)

Excellent Communication Skills

Education

Graduate degree in Biostatistics

Tools

JMP

SAS

R

Job description

Job responsibilities
• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming 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.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, 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. Identifies out of scope tasks and escalate to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• 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.
• Coaches and mentors other Biostatistics staff.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

What were looking for
• Graduate degree in biostatistics or related discipline.
• 3+ years of hands-on CMC experience required with JMP for statistical analysis, including DoE(Design of experiment), statistical approaches: PCA, and PLS.
• Strong understanding of QbD, PQR, and regulatory guidelines (ICH/FDA) required.
• Proficiency in SAS/R programming is essential
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.