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Principal Biostatistician (HEOR/HTA)

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Syneos Health Commercial Solutions

1mo ago

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

AI generated summary

  • You need HEOR/HTA experience, a graduate degree in biostatistics, extensive clinical trial experience, programming skills, strong statistical knowledge, and excellent communication abilities.
  • You will mentor biostatisticians, lead projects, prepare statistical plans, ensure quality control, manage timelines, support programming, and assist in business development and regulatory meetings.

Requirements

  • Previous experience within HEOR and/or HTA is required
  • Graduate degree in biostatistics or related discipline
  • Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies
  • Proficiency in programming
  • Ability to apply extensive 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
  • Experience with regulatory submissions preferred
  • Excellent written and verbal communication skills
  • Ability to read, write, speak, and understand English

Responsibilities

  • Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel.
  • 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.
  • 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), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required.
  • May be responsible as Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
  • 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.
  • Implements company objectives, and creates alternative solutions to address business and operational challenges.
  • As biostatistics representative on project teams, interfaces with other departmental project team representatives.
  • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
  • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications.
  • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
  • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics 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 escalates to management.
  • Provides statistical programming support as needed.
  • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs.
  • Provides input and reviews, and subsequently 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.
  • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
  • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required.

FAQs

What is the role of a Principal Biostatistician at Syneos Health?

The Principal Biostatistician at Syneos Health oversees biostatistics activities on projects, mentors other biostatisticians, prepares statistical analysis plans, and ensures high-quality statistical support throughout the project lifecycle from protocol to clinical study report.

What qualifications are required for this position?

A graduate degree in biostatistics or a related discipline is required, along with previous experience in HEOR and/or HTA, extensive experience in clinical trials, proficiency in programming, and excellent communication skills.

Where is this job position available?

The position is currently open for hiring in the UK, Ireland, Greece, Hungary, Poland, Romania, South Africa, Spain, Ukraine, Argentina, Brazil, Colombia, and Mexico.

What kind of experience is preferred for applicants?

Extensive experience in clinical trials or a combination of education and experience is required, with a preference for experience in regulatory submissions.

Is mentoring a part of the Principal Biostatistician role?

Yes, the Principal Biostatistician is responsible for mentoring biostatistics associates and overseeing their training.

What are the primary responsibilities regarding project deliverables?

The Principal Biostatistician manages statistical tasks, oversees the quality of deliverables, and ensures timelines for project milestones are met while providing statistical programming support as needed.

What is the company culture like at Syneos Health?

Syneos Health emphasizes a Total Self culture that fosters authenticity, diversity, and inclusion, and they are committed to developing their employees through various support programs.

How many employees does Syneos Health have globally?

Syneos Health has approximately 29,000 employees across 110 countries.

Is travel required for this position?

Minimal travel may be required for this position.

What is the focus of Syneos Health's Clinical Development model?

The focus of Syneos Health's Clinical Development model is to bring the customer and the patient to the center of everything, aiming to simplify and streamline processes to enhance collaboration and accelerate the delivery of therapies.

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Syneos Health Commercial Solutions

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.