Principal Statistician Oncology with Submission Experience
Syneos Health
Amsterdam
1 week ago
Principal Statistician Oncology with Submission Experience
Principal Statistician Oncology with Submission Experience needed at Syneos Health. Leads statistical tasks across clinical trial lifecycle, mentors team, and supports regulatory submissions. Requires oncology experience, graduate degree in biostatistics, and 6-8 years of pharmaceutical experience.
Remote
Full-time
Principal
SAS
R
Salary
Not specified
Core Qualifications
Technical (Must-have)
SASRClinical trialsStatistical analysisRegulatory submissionsICH guidelinesDSMBDMC
Soft Skills
mentoringcommunicationproblem solvingteamworktime management
Key Responsibilities
- Serves as a statistical department resource and mentors biostatisticians.
- Directs activities of biostatistics personnel on assigned projects.
- Prepares Statistical Analysis Plans (SAPs) with mock-up displays.
- Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
- Reviews SAS/R annotated CRFs and database design.
- Implements company objectives and creates alternative solutions.
- Interfaces with other departmental project team representatives.
- Conducts verification and quality control of project deliverables.
- May lead complex projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings.
- Manages scheduling and time constraints across multiple projects.
- Monitors progress on study activities against milestones.
- Provides statistical programming support as needed.
- Participates in DSMB/DMC activities.
- Maintains project documentation and ensures inspection readiness.
- Supports business development activities by contributing to proposals and budgets.
- May require minimal travel.
Principal StatisticianOncologyBiostatisticsClinical TrialsSASRRegulatory SubmissionsSyneos HealthRemote