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Senior Recruiter at Connect Life Sciences & Writer
This is a fully onsite role in the Greater Boston Area (5x/week)
This client offers relocation assistance from the US or Canada.
Requirements:
* Bachelor's Degree
* At least ten years of industry experience
* One year of line management experience
Responsibilities:
* Lead and supervise junior level biostatisticians and provide mentoring and guidance using positive, progressive, and proactive management style
* Participate in bid defense presentations and assist with development of budgets and proposals
* Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios
* Perform sample size calculations and write statistical methodology sections for inclusion in study protocols
* Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissions
* Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards, if applicable
* Develop SAS programs to QC statistical tables/figures/data listings
* Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor
* Review and/or write the statistical methods and results sections of clinical study reports
* Review and/or assist in writing publications
* Review case report forms and data validation guidelines to ensure quality and integrity of study data collection
* Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review
* Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis
* Make presentations in industry meetings
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science, Research, and Analyst
Industries
* Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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