Principal Biostatistician (Medical Affairs/HEOR - Europe Only)

Principal Biostatistician (Medical Affairs/HEOR - Europe Only)

Syneos Health® is a leading 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. Our Clinical Development model places the customer and the patient at the center of everything we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Job Benefits

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• We are passionate about developing our people through career development and progression, supportive line management, technical and therapeutic area training, peer recognition and total rewards program.
  
• We maintain a Total Self culture where you can authentically be yourself; we are dedicated to taking care of our people.
  
• We believe diversity of thoughts, backgrounds, cultures, and perspectives helps everyone belong.
  

Open to hiring in the following locations: UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Netherlands, Belgium.

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• Previous experience with HEOR and/or HTA is required.
  
• 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 trains new hires to enhance skills.
  
• 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.
  
• Prepares in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
  
• conducts verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with the SAP and specifications.
  
• May lead complex or multiple projects (e.g., submissions, integrated analyses), and attend regulatory agency meetings or respond 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, discusses time estimates with management, and communicates any difficulties with meeting timelines.
  
• Monitors progress on study activities against milestones and ensures 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 business needs.
  
• 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.
  

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• Must have previous experience with HEOR and/or HTA.
  
• 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.
  

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you can take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Get more information at the website: syneoshealth.com

Tasks, duties, and responsibilities listed are not exhaustive. The company may assign additional tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The company will determine what constitutes as equivalent to the qualifications described above. Nothing herein should be construed as an employment contract. Any language herein is intended to comply with obligations of the country of operation, including the EU Equality Directive, in relation to recruitment and employment. The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.