Principal Biostatistician Morrisville, NC

Principal Biostatistician

Principal Biostatistician job risville, NC. Remote, USA – East Coast. You are an experienced Biostatistician with leadership, client engagement, and strategic influence across the clinical development lifecycle. Caidya is looking for a Principal Biostatistician with expertise in international/global trials who thrives in client-facing environments and has proven experience in RFP and bid defence activities.

Provides all biostatistical services to meet the requirements of all Company clients, including full-service, Global Clinical Analytics (GCA), and other type studies.

• Proven written and oral communications with regulatory agencies.
• Special expertise in more complex statistical analytical methods not well known to all biostatisticians.
• Established expertise in a medical therapeutic area.
• Established a long-term high-level relationship with a Company sponsor.
• Overall high-quality work and a strong reputation for statistical knowledge.
• Exhibited leadership and organizational skills to plan, supervise, implement, and monitor the statistical processes for multiple clinical trials.
• Demonstrated ability to adapt and adjust to changing priorities and deal with uncertainty and risks.
• May be given some supervisory responsibilities for junior staff or department areas.

No supervisory responsibilities.

Education: PhD or Master's in statistics or related area, or equivalent degree globally.

Experience: PhD + 7-10 years (or MS + 10 years) experience in pharmaceutical, CRO, or related environment.

• Interpersonal and communication skills:
  Excellent written and oral communication skills including technical writing of all statistical results.
• Ability to develop professional presentations for presenting statistical issues and solutions to clients internally.
• Ability to effectively learn and handle new or unfamiliar statistical methods.
• Ability to find needed written resources and interact with other Biostatics staff with the needed familiarity.
• Willingness to share expertise with junior staff members.

• Excellent broad ranging understanding of statistical methods and issues. Demonstrates leadership in several areas of statistics.
• Has a developed expertise in 1-2 therapeutic areas.
• Ensures statistical quality:
  Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team.
• Deep working knowledge of clinical drug development process:
  In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts.
• Has strong knowledge of GCP and ICH guidelines and other regulatory guidelines related to statistics.
• Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and/or present oral arguments to such agencies.
• Ability to serve as a Project Manager for GCA studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget.
• Excellent training and presentation skills:
  Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations.
• Strong understanding of departmental and company procedures which relate to tasks that are performed routinely:
  Strong understanding of all departmental SOPs and good understanding of all required company SOPs.
• Familiarity with Company
  
  Functional Area
  
  s that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas.
• Support the Business Development process through RFP process, bid defenses, attendance at scientific meetings, etc.

If you're looking for the next step in your biostatistics career where your leadership, therapeutic expertise, and client-facing skills are truly valued we encourage you to apply now!