The Senior Biostatistician will have experience in all required areas as a Biostatistician II. The Senior Biostatistician is responsible for serving as a study lead. They will apply strong statistical expertise to provide statistical support for clinical trials. This includes generating randomization schedules, participating in protocol development, authoring the SAP, preparing and reviewing programming specifications used in creating derived datasets, tables, listings and figures.

Responsibilities:

• Exceed expectations and responsibilities of a Biostatistician II
• Function independently as a lead statistician to deliver the project tasks/responsibilities to timelines and within budget
• Author the Statistical Analysis Plan (SAP) and TFL shells for assigned studies with limited supervision
• Participate in the design and review of clinical protocols, including preparation of statistical sections, sample size calculations, randomization and statistical methods, defining study objectives and parameters
• Provide randomization scheme and appropriate documentation
• Serve as IDMC/DSMB statistician
• Ensure statistical quality; review and monitor quality of statistical tasks and project deliverables provided by the statistical project team
• Serve as peer reviewer for the work of other statisticians
• Provide input into case report form development
• Participate in department initiatives
• Standard Operating Procedures (SOPs)
• Strong understanding of departmental and company procedures
• Business Development
• Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Additional Responsibilities:
• Assist in the preparation and review of monthly financial reporting
• Promote visibility outside of the functional area and effectively interact cross-functionally and in industry
• Perform other duties as requested by management

Qualifications:

• The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related field
• Minimum of 6 years direct Biostatistics experience in pharmaceutical development or CRO environment
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.