BCI, located in Lexington, MA, provides biostatistical and programming services to the pharmaceutical, biotechnology, and medical device industries. Most of our work is in the design and analysis of clinical trials, although we can also design and analyze epidemiology studies and patient registries. BCI employs a select group of biostatisticians and statistical programmers, all of whom have advanced degrees and whose substantial experience spans Phase 1 to Phase 4 clinical trials and a broad range of therapeutic areas.
Education: MS/MA or Ph.D. in statistics or biostatistics
- Associate Director: Minimum of 10 years of experience with the pharmaceutical, biotechnology and/or medical device industries (including CROs).
- Director: Minimum of 15 years of experience with the pharmaceutical, biotechnology and/or medical device industries (including CROs).
- Knowledge of statistical methodologies applicable to clinical trials
- Knowledge of drug/biologic/device development process
- Excellent knowledge of SAS
- Excellent knowledge of CDISC
- Experience in a range of therapeutic areas and indications
- Ability to produce work of the highest quality
- Ability to work on multiple projects simultaneously
- Ability to meet timelines
- Ability to work well with project team and clients
- Detail oriented
- Excellent oral and written communication skills
- Manage relationships with client sponsors
- Manage projects and staff
- Perform and QC sample size and statistical power calculations
- Write/review statistical sections of study protocols
- Review study protocols
- Perform and QC randomization
- Review design of case report forms
- Develop and review statistical analysis plans including shells for tables, listings, and figures
- Develop specifications for analysis datasets and tables
- Perform statistical review of analysis datasets, tables, listings, and figures
- Conduct statistical analyses
- Write/review statistical sections of clinical study reports
- Provide statistical expertise/training to others with respect to the design and analysis of clinical trials
In addition to vacation, holiday and sick time, benefits include medical, dental, vision and disability insurances, FSA, 401(k) retirement plan with matching and profit sharing, annual bonus, and professional development.
Job Type: Full-time