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Senior Biostatistician

Revision Date: 05-APR-2025

Primary Function of Position

Responsible for independently performing moderately complex biostatistics and programming tasks at ARA.

Position Description & Responsibilities

A Senior Biostatistician will be responsible for performing all biostatistical tasks at ARA. They will act independently as a lead biostatistician on multiple projects of moderate complexity and act as support statistician on other projects simultaneously as assigned. As a lead biostatistician on a project, they will be the primary point of contact for the sponsor on biostatistics and programming topics and will manage the project timelines, resourcing and budget for all biostatistics and programming related tasks for that project. Will provide oversight to other, more junior, statisticians in their role as lead statisticians. May serve as a production or validation programmer for datasets or TLFs on a project with other biostatisticians/programmers.

A Senior Biostatistician will serve as the primary statistical resource for assigned projects. Senior Biostatisticians will have a clear understanding of the therapeutic area under investigation providing expert statistical guidance to internal and external project team members and will identify solutions for statistical issues related to their projects.

Statistical consulting responsibilities may include support for clients regarding the conduct of experiments, clinical trials, statistical methodology, and regulatory issues as well as preparing/reviewing submission documents to regulatory agencies and participating in meetings with regulatory agencies.

May be responsible for mentoring other biostatisticians and programmers in technical aspects of supporting statistical deliverables.

Job Responsibilities

  • Write and Review Statistical Analysis Plans and Mock Shells
    Review and provide biostatistical feedback on CRF/Protocol and other study documents.
  • Write and Review SDTM and ADaM Specifications for moderately complex studies.
  • Perform Production and/or Validation Programming of SDTM, ADaM and TLFs for moderately complex studies.
    Perform sample size/power calculations for moderately complex study designs.
  • Create and review randomization specifications for moderately complex studies.
  • Program and/or validate randomizations/materials lists for moderately complex randomization schemes.
  • Prepare and maintain project documentation related to biostatistics and programming activities.
  • Mentor other members of the biostatistics and programming group.
  • Provide technical biostatistical support to both internal and external project teams.
  • Participate in departmental and company process development initiatives, working closely with data management, quality assurance and other staff as required.
  • Maintain awareness of global regulatory developments relevant to design and analysis of clinical trials.
  • Maintain a working knowledge of FDA regulatory guidelines regarding clinical trial analysis and reporting.
  • Contribute to professional activities (meetings, publications) as assignments allow.
  • With other team members, support regulatory filings for clients and support ARA project teams when involved in regulatory filings.
  • Other duties as assigned.

Job Requirements

  • 5+ years of experience performing statistical tasks in clinical research including relevant practical experience.
  • Masters or PhD in statistics and familiarity with advanced methodologies commonly implemented by the pharmaceutical industry.
  • No management/supervisory experience needed.
  • Experience in a service (CRO) type environment is preferred.
  • Working knowledge of SAS software and an excellent understanding of statistical procedures in SAS.
  • Broad knowledge in clinical statistics and its applications.
  • Broad understanding of the regulatory guidance and process in the US and abroad.
  • Thorough knowledge of regulatory rules and guidelines as relevant to clinical trials.
  • Working knowledge of Word Processing software, Microsoft Project, Microsoft Outlook, database software and Spreadsheet software.
  • Excellent written and verbal communication skills including listening, negotiation, and presentation.
  • Proven ability to successfully interface with all levels of employees and management including executive staff.
  • Proven ability to effectively collaborate and communicate throughout all levels of the organization.
  • Ability to work independently on assigned tasks and proactively seek feedback and guidance when needed.
  • Clinical product registration development and regulatory submission experience preferred.
  • Complex and/or international trials experience is preferred.
  • Ability to travel if needed to meet with study sponsors, attend investigator meetings, etc. approx.10% of the time.

characteristics

  • Clear, direct communication style
  • Able to work successfully with different personalities and work styles.
  • Dedicated work ethic with attention to results and productivity.
  • Strong sense of accountability for company and professional goals.
  • Works well under pressure.
  • Able to take the initiative even on unfamiliar tasks.
  • Professional demeanor.
  • Possesses a positive attitude.
  • Entrepreneurial, proactive, detail oriented, and professional
  • Willing to provide “hands-on” statistical leadership to teams and projects when needed.
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