Principal Biostatistician (Biomarker Analyst - EU based)

Principal Biostatistician (Biomarker Analyst - EU based)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

JOB SUMMARY

This position is responsible for leading projects across multiple studies or programs. A Principal Biostatistician acts as the primary contact with the sponsor for all biostatistics-related activities on assigned projects. Provides external statistical consultancy for sponsor companies and serves as a departmental resource for complex statistical questions, study design considerations, and protocol development.

MAJOR TASKS

• Collaborates with representatives from other functions to plan, execute, and analyze all biomarker aspects (including genomics and devices) of clinical studies or biomarker studies in the role of biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician.

• Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects.

• Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects.

• Conducts and designs advanced data analysis for genomics and biomarker statistics, including statistical programming, and designs complex analysis algorithms.

• Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results.

• Works independently on routine and complex statistical questions and tasks.

• Develops and implements standard processes for the analysis of routine biomarker assessments.

• 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 enhances 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.

• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for the opinions of others.

• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expected results and is consistent with analysis described in the SAP and specifications.

• May lead complex or multiple projects (e.g., submissions, 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.

• 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 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.

• 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

• Strong knowledge of biomarker evaluation, particularly in Oncology, ctDNA data, relevant parameters, and underlying biology.

• Graduate degree in Biostatistics or a 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 R 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 throughout 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.