Principal Biostatistician

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

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 Caidya. 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 Caidya 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 Biostat 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 Caidya

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.