Clinipace

Title: Principal Biostatistician Job Description: Job Location: US - Remote Job Overview: Provides all biostatistical services to meet the requirements of all Caidya 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 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. 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 Caidya 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-BG1 #LI-Remote