Job Overview:
Provides all biostatistical services to meet the requirements of all Clinipace 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 Clinipace. 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 Clinipace 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 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 Clinipace 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 defenses, attendance at scientific meetings, etc. #LI-Remote #LI-AC1
