Principal Biostatistician

Job Title: Principal Biostatistician
Location: USA – East Coast, remote

Are you an experienced Biostatistician with experience in 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. This is an exciting opportunity to lead from the front working across high-impact global trials, representing Biostatistics during proposal development, and collaborating with cross-functional teams to deliver best-in-class analytical support.

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

Job Duties and Responsibilities:
A Principal Biostatistician is expected to be a very successful Senior Biostatistician who establishes excellence in one or more areas providing some unique leadership to Company. Examples of areas of excellence include but are not limited to:

• 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.

Supervisory Responsibilities:
No supervisory responsibilities.

Job Requirements:

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.

Skills/Competencies:

• 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.

Capabilities:

• 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 Areas 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