Principal Biostatistician - FSP

About the role

You are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. In this role, you will lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings.

Responsibilities

• Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants
• Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
• 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 under the supervision of a statistical consultant
• Prepare and review of randomization specifications and generation of randomization schedules
• Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
• 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, or work on new initiatives
• Represent the department during audits

Requirements

• Degree in a relevant field such as statistics, computer sciences, etc.
• Solid experience 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®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
• 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. across a variety of trials
• 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

Qualifications

• Experience with clinical trial processes and regulatory requirements
• Experience with statistical software such as SAS, R, or Python
• Experience with clinical trial data management systems (CDMS)
• Experience with data monitoring and quality assurance

Skills

• Statistical analysis and modeling
• Data management and quality assurance
• Project management
• Communication and collaboration
• Leadership and mentoring

Benefits

• All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
• Comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable.

Pay

Pay Range: $115,000-$130,000 USD (The range does not include benefits, and if applicable, bonus, commission, or equity)