Principal Biostatistician – FSP
Employment Information
Job Description
Principal Biostatistician leading complex clinical trials across global pharmaceutical companies. Developing statistical plans and providing oversight with a global project team.
Responsibilities:
- Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs
- Perform project management activities for identified projects including resource planning, timelines and milestone management
- Serve as Data Monitoring Committee Support Statistician
- Lead the development of complex Statistical Analysis Plans
- Conduct overall statistical review of Tables, Figures and Listings for complex studies prior to client delivery
- Review Case Report Form and other study specific specifications and plans
- Develop the statistical sections of the protocol for complex studies
- Preparation and review of randomization specifications and generation of randomization schedules
- Provide mentoring and training to less experienced staff
- Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences
- Attend bid defense meetings for complex studies
- Act as Subject Matter Expert and develop or review procedural documents
- Represent the department during audits.
Requirements:
- Degree in a relevant field such as statistics, biostatistics, public health, etc.
- Masters degree strongly preferred.
- Solid experience (10+ years) of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
- Ability to program in one or more statistical software packages (SAS®)
- SAS proficiency including use of a variety of statistical procedures
- Proven professional experience with SDTMs, ADaM datasets and TFLs
- Proven ability to effectively communicate statistical concepts
- A good knowledge of the overall clinical trial process
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc.
- Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail.
- Business fluency in English – both verbal and written – is a must.
Benefits:
- Medical, Dental, Vision, Life insurance
- STD/LTD
- 401(K) retirement plan
- ESPP
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
Related Jobs
Clinical Scientist
Crinetics Pharmaceuticals
Clinical Scientist working at Crinetics, providing clinical expertise for phase 1 - 3 studies. Collaborating with cross-functional teams on protocol development and medical decision making.
Senior Biostatistician
Veristat
Senior Biostatistician providing statistical input on Phase I-IV clinical trials for Veristat. Analyzing clinical trial data and leading statistical analysis plans.
Clinical Research Physician
Ratio Therapeutics
Clinical Research Physician overseeing clinical trials at Ratio Therapeutics focusing on patient safety and data integrity. Collaborating with teams to facilitate clinical development of new molecules.
Senior Clinical Trial Manager
Peptilogics
Senior Clinical Trial Manager overseeing clinical trials for peptide therapeutics at Peptilogics. Managing operations, compliance, and performance metrics for clinical research studies.
Clinical Scientist
ICON plc
Clinical Scientist role designing and conducting clinical studies at ICON, a global healthcare intelligence organization. Collaborating with teams to advance innovative treatments and adhere to regulatory standards.
Principal Biostatistician
Yuxi Global powered by Veritas Automata
Lead biostatistician providing statistical guidance for clinical trials analysis at Yuxi Global. Reporting on project management, timelines, and client relationships.
Business Development Manager – Clinical Research
SGS
Business Development Manager at SGS identifying and securing business opportunities in the (bio)pharmaceutical sector. Leading client relationships and negotiating deals to drive growth in clinical research.
Key Account Manager – Clinical Research
SGS
Key Account Manager driving growth and building relationships in clinical research. Collaborating with clients and internal teams to ensure exceptional service delivery and satisfaction.
Clinical Research Program Manager
Shriners Children's
Clinical Research Manager overseeing clinical research operations at Shriners Children’s with audit responsibilities and compliance monitoring. Leads educational support for research staff to ensure regulatory adherence.
Account Executive, BioPharma Clinical Research
Paradigm Health
Account Executive responsible for driving revenue by selling AI-driven solutions to pharmaceutical partners. Engaging with biopharma customers to expand market presence and articulate value propositions.
Regional Clinical Study Manager
BeOne Medicines
Regional Clinical Study Manager overseeing regional clinical operations for study delivery in the US. Collaborating with stakeholders and ensuring quality and compliance throughout the study.
Senior Clinical Trial Manager
Syneos Health
Clinical Trial Manager overseeing clinical monitoring and management compliance in biopharmaceutical company. Collaborating with teams to ensure patient safety and protocol integrity.
Sponsor Dedicated Clinical Trial Manager II – Home Based
Syneos Health
Clinical Trial Manager overseeing global studies for biopharmaceutical solutions and vendor management. Collaborating on clinical protocols, timelines, budget management, and team training.
Senior Reg Affairs Specialist – CTA, Clinical Research
Thermo Fisher Scientific
Senior Regulatory Affairs Specialist coordinating regulatory strategies globally on clinical trials. Engaging with clients and regulatory agencies to ensure compliance and quality outcomes.
Senior Biostatistician – FSP
Clinical Outcomes Solutions
Senior Biostatistician providing statistical analysis and support for clinical trials in the pharmaceutical industry. Collaborating with cross-functional teams to ensure compliance with regulatory requirements.
Senior Clinical Trial Manager
Kyverna Therapeutics
Senior Clinical Trial Manager overseeing cell therapy clinical trials from design to close-out. Responsible for timelines, budgets, vendor oversight, and quality evaluations.
Senior Biostatistician
Beacon Biosignals
Senior Biostatistician at Beacon Biosignals analyzing EEG data. Collaborating with scientists and engineers to drive advancements in brain health through data analysis and interpretation.
Senior Clinical Trial Manager, FSP
Thermo Fisher Scientific
Senior Clinical Trial Manager responsible for achieving clinical deliverables remotely. Collaborating with various teams to ensure compliance and operational quality in clinical studies.
Adjunct Lecturer – Regulatory & Clinical Research Management
Regis College
Adjunct Lecturer for Regis College teaching graduate course on Quality Systems & Risk Management. Engage with graduate-level teaching responsibilities in a fully remote capacity.
Adjunct Lecturer – Regulatory & Clinical Research Management, Project Management
Regis College
Adjunct Lecturer teaching Project Management course for Regulatory and Clinical Research Management Graduate Program. Engaging with course preparation, student assessment, and maintaining an inclusive learning environment.