Biostatistician – Degree in Bioinformatics/ Biostatistics

Job Description:
Long-term W2 Contract for Biostatistician with our direct pharmaceutical client based in NJ - New Jersey

• MUST have a Master's or PhD in Bioinformatics or Biostatistics with 1-3 years of pharmaceutical industry experience
• SAS & R are a must along with background in Biomarkers or Genetics/ Genomics

Duties:

• Provide statistical, bioinformatical and data-analytic support for the design and subsequent analyses of oncology biomarkers from clinical studies in conjunction with drug development and registration.
• Particular emphasis will cover all statistical activities enabling data analysis and reporting of biomarker data in and across clinical programs as well as molecular epidemiology studies to adequately support proof of concept, development and life-cycle management of Company drugs.
• Communication with development and regulatory teams as well as external partners through reports and presentations is an essential aspect of this role.
• Ensure timeliness and high quality contribution to all Biostatistics' deliverables, e.g. protocol, study set-up, and analysis plan, analysis reports, regulatory submissions and publications for the assigned clinical projects.
• Follow processes and adhere to Company and project specific standards as well as Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines).
• Responsible for data analysis and reporting of biomarker data in and across clinical studies and programs as well as molecular epidemiology studies.

Skills:

• Proficiency of statistical software packages (R and SAS) are required.
• Proficiency in data visualization is highly desirable.
• Proficiency in common statistical techniques (logistic regression, linear mixed models, Cox proportional hazards model, etc.) to correlate biomarker data with clinical endpoints.
• Experience navigating clinical database is desirable.
• Knowledge of drug development process , Health Authority guidelines and Oncology and/or regulatory activities would be advantageous.
• Knowledge in Bioinformatics/Statistics and its applications to biomarker components of clinical trials is preferred.
• Experience in application of statistical/bioinformatics techniques to biomarker data across different platforms (NGS, flow cytometry, etc.) is a plus.
• Good understanding of genetics/genomics, cell-based assays and diagnostic development is preferred.

• Master/ Ph.D. degree in Biostatistics or Bioinformatics (or equivalent degree) with at least 1-3 years of pharmaceutical/related experience

Requeriments :

• M.Sc. or higher Degree in Bioinformatics

Skills :

• Bioinformatics
• Biomarker Discovery
• Genetics
• genomic
• Next Generation Sequencing
• Programming in R
• Programming in SAS
• Statistics

[Click Here to Access the Original Job Post]