CyberCoders Senior Biostatistician with clinical trial experience in Cambridge, Massachusetts
Senior Biostatistician with clinical trial experience Senior Biostatistician with clinical trial experience - Skills Required - Statistical Analysis Plans, SAS Programming, CDISC Data Standards and Models, Clinical Research Regulatory Requirements
Join a dynamic team of experienced Biostatisticians within a full service innovative clinical research organization. Work with large and small sponsors to support Phase I-IV studies, focusing on innovative devices and pharmaceutical solutions for a variety of indications, including MS, oncology, ophthalmology, and other indications. Collaborate with our outstanding clinical operations, database programming, biostatistics, and medical writing teams to help sponsors plan and conduct high quality, compliant, and efficient clinical research.
What You Will Be Doing
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.
Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
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.
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.
Support proposal development and attend bid defense meetings.
Review Request for Proposal (RFP) and Scope of Work (SOW) documents.
What You Need for this Position
PhD degree in biostatistics, mathematics, statistics, public health or related discipline with 3+ years experience in statistical analysis of clinical trials data or MS degree in biostatistics, mathematics, statistics, public health or related discipline with 5+ years of experience in statistical analysis of clinical trials data.
Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
Proficiency in SAS statistical programming.
Knowledge of other statistical and data management software packages is a plus.
Strong written and oral communication skills.
Knowledge and experience with CDISC data standards and models.
Strong project management and mentoring/leadership skills.
In-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Ability to effectively manage multiple tasks and projects.
Ability to clearly describe statistical techniques and interpret results.
So, if you are a Sr. Biostatistician with experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Senior Biostatistician with clinical trial experience MA-Cambridge BF2-1398096