Principal Biostatistician – Integrated Analysis Experience Required
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Principal Biostatistician leading integrated analyses, regulatory submissions, and statistical strategy for Syneos Health’s life-sciences clients. Remote across approved European locations.
Responsibilities:
- Lead projects across multiple studies or programs
- Act as primary sponsor contact for biostatistics activities
- Provide statistical consultancy and serve as a resource for complex statistical questions, study design, and protocol development
- Mentor biostatisticians and oversee or develop training plans and materials
- Direct biostatistics personnel and independently review project work
- Support statistical tasks throughout the project lifecycle, from protocol to CSR
- Prepare or oversee Statistical Analysis Plans and mock-up tables, listings, and figures
- Lead statistical aspects of protocols, randomization schedules, and clinical study reports as needed
- Create or review programming specifications for analysis datasets, tables, listings, and figures
- Review SAS-annotated CRFs, database design, and study documentation
- Interface with cross-functional project team representatives
- Conduct verification and quality control of project deliverables
- Lead complex or multiple projects, including submissions and integrated analyses
- Support regulatory agency meetings and responses to regulatory questions
- Manage schedules, priorities, milestones, timelines, and out-of-scope tasks
- Provide statistical programming support as needed
- Participate in DSMB/DMC activities, including charter development and statistician service
- Follow applicable SOPs, WIs, and regulatory guidelines such as ICH
- Maintain complete, current project and quality-control documentation for inspection readiness
- Support business development through proposals, budgets, and sponsor bid defense meetings
- Perform other assigned work-related duties
Requirements:
- Graduate degree in biostatistics or related discipline – Master Degree (minimum)
- Hands-on integrated analysis experience with IASAP and TLF specifications, additional derivations, draft table reviews, and planning/coordinating analyses to support labeling
- Deep understanding of clinical development plans and submission strategy, with experience contributing to submission planning and Benefit/Risk analyses
- Ability to independently manage regulatory authority requests and partner with clinical teams
- Extensive experience in clinical trials or an equivalent combination of education and experience
- Proficiency in programming
- Extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research
- Experience across all statistical tasks supporting clinical trials from protocol to CSR
- Experience with regulatory submissions preferred
- Excellent written and verbal communication skills
- Ability to read, write, speak, and understand English
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Minimal travel may be required
Similar Jobs
Clinical Research Budget Analyst
Clinical Research Budget Analyst translating trial budgets and payment terms into CRIO for Headlands Research’s clinical trial site network. Supporting invoicing, collections, and cross-functional study operations.
Clinical Research Associate – Neurology, Oncology
Clinical Research Associate managing neurology and oncology trial sites for Worldwide Clinical Trials, a global CRO. Conducting monitoring, compliance, safety, and data-quality activities remotely in Bulgaria.
Clinical Trial Specialist, French Speaking
Clinical Trial Specialist supporting French-speaking site start-up, TMF management, and regulatory submissions for Emerald Clinical Trials, a global clinical research CRO.
Senior Clinical Research Associate, Belgium
Senior Clinical Research Associate monitoring pharmaceutical and biotech clinical trials in Belgium. Ensuring site compliance, data quality, documentation, and audit readiness through remote and on-site visits.
Principal RWE Biostatistician
Principal RWE Biostatistician leading causal inference, machine learning, and real-world evidence analytics for Cytel’s pharmaceutical clients. Delivering regulatory-grade insights from large-scale healthcare data.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare research organisation. Ensuring protocol compliance, data integrity, and patient safety across German sites.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trials for Thermo Fisher Scientific. Ensuring site compliance, data integrity, regulatory adherence, and audit readiness across clinical studies.
Clinical Research Associate – Single Sponsor
Clinical Research Associate monitoring Austrian clinical sites for Syneos Health’s biopharmaceutical studies. Ensuring GCP compliance, data integrity, site performance and audit readiness.
Clinical Research Associate, FSP
Clinical Research Associate monitoring sites, data, safety, and compliance for Parexel’s clinical development services. Supporting trial timelines, audits, issue resolution, and junior CRA mentoring.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, and patient safety.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trial sites for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, and successful trial execution.
Senior Biostatistician – Clinpharm
Senior Biostatistician supporting SAPs, PK/PD analyses, and clinical trial statistics at Syneos Health. Applying SAS and CDISC standards across Phase I clinical pharmacology studies.
Clinical Trial Manager
Clinical Trial Manager overseeing clinical trial operations, data, protocols, and regulatory compliance for ICON, a global healthcare intelligence organization.
Senior Clinical Research Associate I
Senior Clinical Research Associate monitoring AstraZeneca clinical trials and study sites remotely in Vietnam. Managing site performance, regulatory compliance, data quality, and monitoring activities.
Clinical Research Associate II
Clinical Research Associate monitoring AstraZeneca clinical trial sites in Vietnam. Supporting study start-up, site performance, regulatory compliance, data quality, and inspections.
Lead Clinical Research Associate
Lead CRA overseeing regional clinical trial quality for PSI CRO, a global contract research organization. Mentoring monitors and coordinating compliance, data integrity, and study operations remotely.
Senior Clinical Research Associate – CNS/Oncology
Senior Clinical Research Associate managing CNS/Oncology clinical studies for Worldwide Clinical Trials, a global CRO. Overseeing site start-up, maintenance, compliance, and study closeout across the UK.
Senior Clinical Research Associate – CNS/Oncology
Senior Clinical Research Associate managing UK CNS/Oncology clinical research sites for global CRO Worldwide Clinical Trials. Overseeing study start-up, site maintenance, safety reporting, and closeout.
Senior Clinical Research Associate
Senior Clinical Research Associate advancing AbbVie’s oncology medicines through clinical site oversight in China. Ensuring trial compliance, data integrity, patient safety, recruitment and investigator partnerships.
Clinical Trial Manager
Clinical Trial Manager coordinating clinical research project delivery at ICON. Leading teams, managing timelines and budgets, and ensuring quality outcomes for faster patient access to medicines.