Job Title

• Statistician 

Position Responsibilities

• Skilled scientist with training and significant experience in statistics, drug development, and clinical research.
• This position will provide opportunities for independent and/or leadership contributions to clinical trials and drug development programs.
• The Statistical Consultant needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks.
• He or she is expected to work collegially and closely with clinical research staff and senior statistical staff to determine appropriate study designs, sample size estimates, and write appropriate sections of study protocols.
• The position is also responsible for writing statistical analysis plans, analyzing data, and writing sections of clinical study reports and registration documents. .
  

Position Requirements

• Ph.D. in Statistics/Biostatistics (or related field), or MS/MA with a minimum of 2 years of experience, is required.
• Good presentation and written communications skills.
• Ability to communicate with non-statisticians to interpret statistical findings 
• He or she must have excellent written and oral communication skills
• Good organizational and problem-solving skills.
• Ability to program proficiently using SAS
• Ability to write SAS programs to perform efficacy and safety analyses
• Knowledge of CDISC SDTM and ADaM
• Knowledge of relevant FDA and CHMP guidelines
• Experience with regulatory submissions in the US
• Experience with regulatory submissions outside the US desirable
• Knowledge and understanding of therapeutic-specific regulatory guidelines and perspective is preferred.
• Knowledge of techniques for demonstrating non-inferiority and bioequivalence highly desirable.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance