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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, proficiency in programming, strong communication skills, and experience in statistical tasks from protocol to CSR.
  • You will support statistical tasks, prepare analysis plans, review datasets, ensure timely project completion, mentor staff, and engage in business development while adhering to regulatory guidelines.

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.
  • Early Phase:
  • 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 location for candidates applying for this role?

Preferred candidates are located in Europe, with a preference for those who can join with less than 3 months' notice. For the US, candidates must be situated on Central or East Coast hours, as West Coast hours are not acceptable.

What level of experience is required for this position?

This position is designed for candidates with moderate experience in clinical trials or an equivalent combination of education and experience. For the Early Phase specialization, typically 5+ years of experience is required.

Is a specific degree necessary for this role?

Yes, a graduate degree in biostatistics or a related discipline is required.

What programming skills are expected for this position?

Proficiency in programming is required, along with the ability to apply knowledge of statistical design, analysis, and relevant regulatory guidelines utilized in clinical research.

What specific experience is preferred for the Early Phase specialization?

Candidates should have experience in Phase 1 trials, including dose escalation, dose finding, pharmacodynamics (PD), pharmacokinetics (PK), and population PK, as well as non-oncology studies.

What are the main responsibilities of the Principal Biostatistician?

Key responsibilities include providing statistical support throughout the project lifecycle, preparing Statistical Analysis Plans (SAPs), coordinating with other biostatisticians, conducting quality control, and managing project timelines.

Is travel required for this position?

Minimal travel may be required.

What type of culture does Syneos Health promote?

Syneos Health promotes a Total Self culture, encouraging employees to authentically be themselves, and emphasizes diversity of thought, backgrounds, and perspectives.

What benefits are offered for this position?

Benefits include health insurance (medical, dental, and vision), a company match 401k plan, eligibility for an Employee Stock Purchase Plan, commissions/bonuses based on performance, and flexible paid time off (PTO) and sick time.

What is the salary range for this position?

The annual base salary for this position ranges from $95,000 to $175,700 USD, with actual salary varying based on candidate qualifications, skills, competencies, and proficiency for the role.

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.