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Principal Biostatistician (Early Phase)

  • Job
    Full-time
    Senior Level
  • Science
    Research & Development
  • Madrid

AI generated summary

  • You need a graduate degree in biostatistics, 5+ years in early phase trials, strong programming skills, and excellent communication. Experience with dose-escalation and relevant statistical tasks is essential.
  • You will manage statistical tasks, prepare analyses, coordinate teams, ensure data quality, support project timelines, mentor staff, and contribute to business development while maintaining documentation.

Requirements

  • * Graduate degree in biostatistics or related discipline.
  • * Moderate experience in clinical trials or an equivalent combination of education and experience.
  • * Proficiency in programming.
  • * Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
  • * Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
  • * Excellent written and verbal communication skills.
  • * Ability to read, write, speak, and understand English.
  • * Principal\Senior Biostatistician (5+ years EP experience)
  • * PhD/strong MSc
  • * Phase 1, Dose-escalation, Dose Finding, PD, PK, Pop PK
  • * Non-Oncology

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.

FAQs

What is the preferred notice period for candidates applying for this position?

The preferred notice period for candidates is less than 3 months.

What qualifications are required for the Principal Biostatistician position?

A graduate degree in biostatistics or a related discipline is required.

How much experience is necessary for this role?

Candidates should have moderate experience in clinical trials or an equivalent combination of education and experience.

What type of programming skills are expected for this position?

Proficiency in programming is required for the role.

Which phases of clinical trials will the Principal Biostatistician be involved in?

The role primarily involves early-phase clinical trials, including Phase 1, Dose-escalation, Dose Finding, PD, PK, and Pop PK studies.

What other responsibilities does the Principal Biostatistician have?

Responsibilities include preparing Statistical Analysis Plans, managing project timelines, mentoring staff, and supporting business development activities.

Is experience in oncology required for this position?

No, experience in oncology is not required; the position focuses on non-oncology areas.

What kind of support does Syneos Health provide for employee development?

Syneos Health is committed to developing its people through career development, training, and a supportive management culture.

Are there any travel requirements for this position?

Minimal travel may be required for the role.

What is the salary range for the Principal Biostatistician position?

The annual base salary for this position ranges from $95,000 to $175,700 USD, depending on qualifications and experience.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.