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- Tasks: Lead statistical projects, mentor biostatisticians, and ensure high-quality work in clinical trials.
- Company: Syneos Health is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success.
- Benefits: Enjoy career development, a supportive culture, and the chance to make a real impact.
- Why this job: Join a passionate team that values diversity and innovation while changing lives through healthcare.
- Qualifications: Graduate degree in biostatistics with experience in Medical Affairs or HEOR required.
- Other info: Open to candidates in Europe and North America; minimal travel may be needed.
The predicted salary is between 48000 - 72000 £ per year.
Principal Biostatistician (Medical Affairs/HEOR – EMEA and NA Based))
Join to apply for the Principal Biostatistician (Medical Affairs/HEOR – EMEA and NA Based)) role at Syneos Health
Principal Biostatistician (Medical Affairs/HEOR – EMEA and NA Based))
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Description
Principal Biostatistician (Medical Affairs/HEOR – EMEA and NA Based))
Description
Principal Biostatistician (Medical Affairs/HEOR – EMEA and NA Based))
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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll 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
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Open to hiring in Europe and NA.
2 Openings: 1 standard Medical Affairs + 1 HEOR/HTA specific role.
- 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.
Qualifications
- Must have previous experience with Medical Affairs and/or HEOR and 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.
Get to know Syneos Health
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’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research, Analyst, and Information Technology
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Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services
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Principal Biostatistician (Medical Affairs/HEOR - EMEA and NA Based)) employer: Syneos Health
Contact Detail:
Syneos Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Biostatistician (Medical Affairs/HEOR - EMEA and NA Based))
✨Tip Number 1
Familiarise yourself with the latest trends and developments in Medical Affairs and HEOR. This will not only help you understand the role better but also allow you to engage in meaningful conversations during interviews, showcasing your passion and knowledge.
✨Tip Number 2
Network with professionals already working in biostatistics or related fields. Attend industry conferences or webinars where you can meet potential colleagues from Syneos Health. Building these connections can provide valuable insights and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific projects you've worked on that relate to the responsibilities listed in the job description. Be ready to explain your role, the challenges faced, and how you contributed to the success of those projects, as this will demonstrate your hands-on experience.
✨Tip Number 4
Showcase your leadership skills by discussing any mentoring or training experiences you've had. Since the role involves overseeing and developing training plans for biostatistics associates, highlighting your ability to lead and support others will make you a strong candidate.
We think you need these skills to ace Principal Biostatistician (Medical Affairs/HEOR - EMEA and NA Based))
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Medical Affairs and HEOR. Emphasise your statistical programming skills and any leadership roles you've held in clinical trials.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biostatistics and your understanding of the role. Mention specific projects or experiences that align with the responsibilities listed in the job description.
Highlight Communication Skills: Since excellent written and verbal communication skills are crucial, provide examples in your application where you effectively communicated complex statistical concepts to non-statistical audiences.
Showcase Your Problem-Solving Abilities: In your application, include instances where you've successfully navigated challenges in project management or statistical analysis. This will demonstrate your ability to adapt and find solutions in a fast-paced environment.
How to prepare for a job interview at Syneos Health
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with statistical design and analysis in detail. Highlight specific projects where you applied your knowledge, especially in Medical Affairs or HEOR, as this will demonstrate your suitability for the role.
✨Prepare for Technical Questions
Expect technical questions related to programming and statistical methodologies. Brush up on your SAS skills and be ready to explain how you've used programming in clinical trials, as this is crucial for the position.
✨Demonstrate Leadership Skills
Since the role involves mentoring and overseeing other biostatisticians, be ready to share examples of how you've led teams or projects in the past. Discuss your approach to training and developing others in the field.
✨Understand the Company Culture
Familiarise yourself with Syneos Health's Total Self culture and their commitment to diversity and inclusion. Be prepared to discuss how you can contribute to this culture and align with their values during the interview.
