Description For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work. Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work. We do things differently than large CROs and would love to have you join our Veristat team! Biostatistician II Key Purpose: The Biostatistician II performs the analysis of clinical trial data and provides statistical input into the reporting of clinical trial results, working to the large extent independently with minimal oversight from the Director or Manager of Biostatistics, or Senior Biostatistician. Primary Duties + Responsibility: Provides 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). Communicates with clients regarding study protocol or statistical analysis issues. Writes detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures. Analyzes clinical trial data producing accurate results representing the outcome of the trial. Validates statistical output. Accurately interprets statistical results and concepts. 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. Provides input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e. g. , statistical methodology standards, standard data presentations). Participates in interactions with regulatory agencies, as required. Collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues. Experience & Minimum Requirements: PhD degree in Statistics, Biostatistics, or related field with relevant academic experience OR a Master’s degree in Statistics or Biostatistics or a related field and 3 years of biostatistical experience in the clinical trials or health research environment required. 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 required. SAS proficiency including BASE and STAT; GRAPH preferred. Proficiency in Microsoft Word and Excel. Strong level of detail orientation. Ability to work on multiple tasks under tight timelines.
Barcelona, Catalonia, ES
|Puesto de trabajo:||Biostatistician II|
|Añadido el:||29. 3. 2022
Puesto de trabajo activo
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