A global Pharmaceutical organization responsible for the clinical development of drug candidates in the United States is seeking a Statistical Specialist to work closely with Clinical and R+D teams. Recently established in the Boston area, our new office will be ready early next year. In the meantime, we’re seeking candidates who are comfortable working remotely much of the week with ability to come into our shared office for meetings and as needed.
As a Statistical Specialist, you should be an experienced Masters or Ph.D. level Statistician with 3-5 years of experience in pharmaceuticals.
Your day to day:
- Provide statistical support to the clinical and R+D teams
- Contribute to efficient study design, prepare statistical consideration sections and provide input into other protocol sections.
- Prepare statistical analysis plans
- Analyze clinical trial data; work with programmers to provide tables, listings, and graphs, including ad hoc validation.
- Review, synthesize, interpret and report analysis results.
- Provide ad hoc data-driven analyses.
- Provide statistical input for the preparation of final study reports and other required documents.
- Support preparation of manuscripts.
- Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
- Provide project requirements to data management team for programming
What we're looking for:
- Masters or Ph.D. in statistics with a focus on statistical methods appropriate for clinical trials
- Demonstrated skill in the analysis and reporting of clinical trials.
- Knowledge of statistical methodologies and statistical regulatory requirements.
- Knowledge of statistical computing software (e.g. SAS or R).
- Knowledge of MS Office products (Word, Excel, PowerPoint)
- Strong knowledge of clinical trial design concepts.
- Knowledge of the clinical drug development process.
- Experience working in a team environment with other clinical team members.