Principal/Director level Biostatistician - Submissions experience - Remote or office based.
We are seeking a Principal/Director level Biostatistician to join our high growth global Clinical Research Services business unit.
The ideal candidate will have extensive Submissions experience, FDA experience but be excited by project work also.
The Director of Biostatistics provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Responsibilities include: providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data); communicating with clients regarding study protocol or statistical analysis issues; and writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures.
The Director of Biostatistics analyzes clinical trial data producing accurate results representing the outcome of the trial, validates statistical output, accurately interprets and clearly communicates statistical results and concepts to non-statisticians. With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. The Director of Biostatistics also provides statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
The Director of Biostatistics provides input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participates in interactions with regulatory agencies, as required. In addition, the Director of Biostatistics collaborates effectively with members (internal and external) of clinical trial implementation teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance..
The Director of Biostatistics is the key client interface for all statistical issues and discussions. Leads the cross functional internal team members to ensure that project work is completed on time, on budget, and with high quality. Communicates to Project Manager and Senior Director of Biostatistics on key client and project issues that require change of scope for the project and/or management of client relationships. Participates with the preparation of client proposals including presenting at business development meetings with potential and current clients. Present at industry conferences representing Cytel and assisting with the Business Development activities at key conferences and industry meetings. Leads or participates as a key member of process improvement initiatives.
The Director of Biostatistics is responsible for the career development and management of direct reports (if applicable). This includes performance reviews, mentoring, one-on-one discussions, and resolution of team or personnel issues.
Qualifications and Experience:
Minimum Education and Work Requirements:
PhD degree in Statistics or Biostatistics or related field with some applied statistics training relevant to the clinical trials or health research environment, and with five (5) years of relevant work experience
OR a Masters degree in Statistics or Biostatistics or a related health science field and at least 8 years Biostatistical experience in the clinical trials or health research environment
Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required.
Ability to lead multi-functional teams across multiple locations
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