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JPN-Tokyo-Hybrid, Japan
Hybrid
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
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.
JOB 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 Biostatician 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.
QUALIFICATION REQUIREMENTS
- 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.
We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
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.
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.