Senior biostatistician contractor New Jersey

monfrair Biostatistician

Senior biostatistician contractor New Jersey

#biostatistics #oncology #NJ

On-site position, no relocation or sponsorship available.

Department: ONCOLOGY BIOSTATISTICS

Senior Biostatistician contractor New Jersey

Duties: Provide statistical, data analytic support for the design and subsequent analyses of oncology biomarkers from clinical studies in conjunction with drug development and registration. The candidate will work with cross-functional teams of precision medicine lead, clinical and regulatory experts, and be responsible for the successful development of drugs for  Oncology programs.

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  Oncology pipeline and drugs. This also includes the contextualization of the statistical results in their biological context and the clinical interpretation of biomarkers.

Communication with development and regulatory teams as well as external partners through reports and presentations is an essential aspect of this role.

Skills: 

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 and project specific standards as well as Health Authority requirements (SOPs, BGs, Master Analysis Plan, GCP, and regulatory guidelines).

Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and cross functional experts.

Responsible for data analysis and reporting of biomarker data in and across clinical studies and programs as well as molecular epidemiology studies.

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.

Good communication and presentation skills and good team player.

Senior Biostatistician contractor New Jersey

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

Apply in the comments section below or by clicking on this link:  http://exigentgroup.catsone.com/careers/index.php?m=portal&a=details&jobOrderID=9321634

 

Senior biostatistician contractor New Jersey