JOB DESCRIPTION

Job Tittle - Biostatistician

As a Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. providing statistical support to clinical studies reviewing analysis datasets and efficacy TLFs performing statistical analyses interpreting statistical results preparing clinical study reports, including integrated summaries for submissions utilizing your strong communication skills to present and explain the methodology and consequences of decisions in lay terms. serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.; being adaptable and flexible when priorities change. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES Excellent written and oral communication skills including grammatical/technical writing skills. Excellent attention and accuracy with details In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Familiarity with moderately complex statistical methods that apply to applicable clinical trials. Strong individual initiative Strong organizing skills Strong working knowledge of SAS computing package Familiarity with other relevant statistical computing packages such as query Strong commitment to quality Ability to effectively manage multiple tasks and projects. Ability to lead and co-ordinate small teams. Ability to solve moderately complex problems. Working knowledge of relevant Data Standards (such as CDISC/ADaM)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
PhD in biostatistics or related field and 1-year relevant experience; Master's degree in biostatistics or related field and 3 years relevant experience; Bachelor's degree in biostatistics or related field and 5 years relevant experience; or equivalent combination of education, training, and experience.