Job description

Duties:

• Act as core team member/lead biostatistician of assigned clinical trial(s). Accountable for clinical trials assigned to direct reports.
• Manage and oversee the work of a small biostatistics team and may indirectly manage cross functional or matrix teams as appropriate
• Provide technical/statistical leadership to multiple and/or complex clinical projects in collaboration with cross-functional teams
• Provide statistical insight/strategies to study design for complex clinical studies
• Develop a robust talent development plan in alignment with functional growth strategies of the department
• Develop and lead the implementation of biostatistics strategies which may include negotiations with internal and external parties
• Provide guidance on process improvement projects within biostatistics and cross-functional areas
• Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization
• Manage activities with accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams
• Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement)
• Make resource planning and budgetary recommendations on operational expenditure planning and other financial activities
• Other incidental duties

Skills:

• Proficiency in a statistical programming language such as SAS and R
• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite
• Proven track of successful experience in NDA/IDE/PMA/PMDA/CE mark submissions
• Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
• Expert understanding of related aspects of biostatistics processes and/or systems
• Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
• Capable of independently leading pivotal trials
• Experience using PASS or EAST
• Experience in trial simulations for sample size and power calculation
• DMC/DSMB experience
• Familiar with survival, regression and categorical data analysis methods
• Medical Device experience
• Adaptive design experience
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Strict attention to detail

Education:

Master's Degree in Statistics or Biostatistics, with 9 years of previous analytical experience in clinical trials, or Ph.D. in Statistics or Biostatistics, with 6 years of previous analytical experience in clinical trials

Job Type: Full-time

Pay: $93.00 - $95.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Master's (Preferred)

Experience:

• Clinical trials: 9 years (Preferred)
• Statistics or Biostatistics: 5 years (Preferred)
• statistical programming language such as SAS and R: 5 years (Preferred)

Work Location: Remote

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