Statistician/Junior Statistician

Frontage Laboratories•Secaucus, NJ

2d•$60,000 - $100,000•Remote

About The Position

We are seeking a detail-oriented and analytical Junior Statistician/Statistician (title based on education & experience) to join our Clinical Data team. In this role, you will assist in analyzing clinical trial data, generating statistical summaries, and ensuring compliance with regulatory standards. You will work closely with senior biostatisticians and clinical data managers to support the statistical design, implementation, and analysis of clinical studies. This is a position ideal for someone with 3-5 years of experience looking to grow and expand their career in statistical analysis and data science.

Requirements

Bachelor’s (4-5 years of experience) OR Masters (3-4 years of experience) degree in Statistics, Mathematics, Biostatistics, Data Science, or a related quantitative field.
Excellent communication skills & good programming skills in SAS, S-plus or other statistical software, and ability to work in a team environment.
Knowledge of concepts and methodologies of QA and relevant regulatory requirements.

Nice To Haves

Master’s degree preferred.

Responsibilities

Implementation and execution of methodological and statistical aspects of clinical studies.
Manage biostatistical activities related to drug product development for assigned clinical studies.
Collaborate with study teams internally and with clients, manage study timelines, and ensure quality of statistical analysis output.
Perform descriptive and inferential analysis of Clinical data and provide statistical assistance in clinical trials and collaborate with Clinical Research and Medical Writing groups on clinical trial protocols, case report forms, statistical analysis plans and other study related documents.
Write, validate and work on biostatistical programs for development of a Statistical Analysis Plan, statistical analysis and derived analysis datasets.
Ensure the accuracy and quality of the statistical analysis output.
Manage study resources and timelines.
Have in-depth knowledge of FDA and ICH guidelines and regulations and industry data standards, e.g., CDISC, SDTM and ADaM.
Develop, revise and/or review SOPs relating to biostatistical services.
May provide statistical expertise and advice for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies.