Senior Manager or Manager of Biostatistics

Biostatistical Consulting Inc. (BCI) is hiring a Senior Manager (or Manager, depending on experience) of Biostatistics. This is a client-facing role combining biostatistical expertise with project management. The successful candidate will oversee statistical and programming services in support of clinical trials across a wide range of therapeutic areas, primarily focused on the design and analysis of trials to advance the development of new drugs, biologics, and devices. 

Located in Lexington, MA, BCI 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, but we are also familiar with the design and analysis of 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.

Responsibilities

The (Senior) Manager position includes the following responsibilities:

• Manage projects
• Perform and QC sample size and statistical power calculations
• Write/review statistical sections of study protocols
• Perform and QC randomization for study protocols
• Review design of case report forms
• Develop and review statistical analysis plans including shells for tables, listings, and figures
• Develop or validate SAS programs to produce derived datasets
• Develop or validate SAS programs to conduct statistical analyses of clinical trials and to produce tables, listings, and figures
• Develop or validate SAS programs to produce tables, listings, and figures for ISEs and ISSs
• Draft responses to FDA or other regulatory authority questions
• Write/review statistical sections of clinical study reports

Qualifications

Education: MS/MA or Ph.D. in statistics or biostatistics

Professional experience:

• Senior Manager: Minimum of 8 years of experience with clinical trials in the pharmaceutical, biotechnology and/or medical device industries (including CROs) or in an academic setting.
• Manager: Minimum of 6 years of experience with clinical trials in the pharmaceutical, biotechnology and/or medical device industries (including CROs) or in an academic setting.

Other requirements:

• Knowledge of statistical methodologies applicable to clinical trials
• Knowledge of drug/biologic/device development process
• Excellent knowledge of SAS and 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 teams and clients
• Detail oriented
• Excellent oral and written communication skills

Benefits:

• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Profit sharing
• Visa sponsorship
• Vision insurance

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.

H-1B Sponsorship can be provided, if needed.