Principal Biostatistician - Future Roles (Netherlands)
Updated: Yesterday
Location: Amsterdam, NH, Netherlands
Job ID:25109659
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.
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 continuously build the company we all want to work for and our customers want to work with. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives we create a place where everyone feels like they belong.
Job Responsibilities
- Serve as a statistical department resource, mentor biostatisticians on job skills, oversee or develop training plans or materials for Biostatistics associates. Conduct training sessions, or otherwise train new hires and enhance the skills of existing personnel.
- Prepare Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborate with sponsor, if required.
- Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
- Review SAS annotated case report forms (CRFs), SAS 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.
- Create or review programming specifications for analysis datasets, tables, listings, and figures.
- Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work. Provide independent review of project work produced by other statisticians in the department.
- Implement company objectives, and create alternative solutions to address business and operational challenges.
- Serve as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
- Conduct and participate in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in SAP and specifications.
- Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, discuss time estimates for completion of study‑related activities with biostatistics management, adapt to timeline or priority changes, reorganize daily workload, and proactively communicate to biostatistics management any difficulties with meeting these timelines. Monitor progress on study activities against agreed‑upon milestones and ensure the study timelines for project deliverables are met. Identify out‑of‑scope tasks and escalates to management.
- Provide 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.
- Lead projects involving 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.
- Provide input and reviews, and subsequently follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and relevant regulatory guidelines (e.g., International Conference on Harmonization (ICH)).
- Maintain well‑organized, complete, and up‑to‑date project documentation, and verification/quality control documents and programs; ensure inspection readiness.
- Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
- Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
- Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
- Perform other work‑related duties as assigned.
- Minimal travel may be required.
Equal Opportunity Employer
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. This position is open to all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, or disability status.
For more information, visit http://www.syneoshealth.com