Experienced CRO Biostatistician, Full Time Cytel Software
Join Cytel, the world leader in the design, interim monitoring and software development of adaptive clinical trials. An adaptive trial utilizes accumulating data to modify aspects of the study as it continues, without undermining the validity and integrity of the trial. This is one of the most exciting advances in clinical trial design in the past 20 years and is beginning to have a huge impact within the biopharmaceutical industry.
If you have a Ph.D. or Masters degree in Statistics or Biostatistics or a related health science field (i.e. MPH), possess an entrepreneurial spirit, and are excited at the prospect of working at a dynamic company involved in state-of-the-art research, development and implementation of new ways to run trials, we want to talk to you.
Prior clinical trials experience is helpful but talent, enthusiasm and excellent communication skills are more important. Familiarity with Bayesian methods, including WinBUGS, is a plus.
At Cytel, you will grow professionally through consulting interactions with biopharmaceutical clients and through participation in the development of breakthrough software that is helping leading companies, government agencies and research centers change the way clinical trials are designed and conducted. Cytel's software products East, StatXact and LogXact are unique, award winning design and analysis tools used by 47 of the top 50 biopharmaceutical companies, as well as academic research sites and the FDA.
Based either in our Cambridge, MA or Chesterbrook PA office, the Biostatistician performs analysis of clinical trial data and provides statistical input into the reporting of clinical trial results. Responsibilities include:
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.
Work with the Senior Biostatistician(s) to design adaptive clinical trials that involve innovative statistical methods.
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.
1-5 years biostatistical experience in the clinical trials or health research environment with a Ph.D. in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment OR Masters degree in Statistics or Biostatistics or a related health science field (i.e. MPH). 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. SAS proficiency including BASE and STAT; GRAPH preferred. Utmost attention to detail and accuracy is absolutely required.
The candidate should have a broad knowledge of statistical methodology, including both Bayesian and frequentist methods. Plus a broad knowledge of software packages such as SAS, R, S-Plus, and Winbugs.
The position is full-time and reports to the Vice President of Clinical Services.
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
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