Clinical Data Biostatistician Job

CLINICAL BIOSTATISTICIAN needed for a CONTRACT opportunity with Yoh's client located in Somerset, NJ.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Clinical Data
- Data Analysis Reporting

WHAT YOU'LL BE DOING:

- Perform validation of clinical reports including tables, listings, graphs, and patient profiles developed by statistical programming staff.
- Validate the statistical models and methods proposed for conducting statistical analysis on clinical trial data.
- Develop the analysis specifications for projects involving pooling of data from multiple clinical trials.
- Review and provide input in design of case report forms, development of statistical analysis plan, and data management plans. Review and approve programming specifications developed by programming staff.
- Provide oversight and monitoring on programming project deliverables and ensure that the staff follows necessary processes while executing the project.
- Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required from customer specific SOPs and processes.
- Act as a point of contact from the division to address any customer concerns and work on investigating the quality issues.
- Act as a liaison between the upper management and project teams and communicate the quality issues in a timely manner.
- Write statistical reports, develop statistical analysis plans and work as a point of contact in project specific meetings.

WHAT YOU NEED TO BRING TO THE TABLE:

- Masters degree in Biostatistics, Statistics, or Mathematics.
- At least three to five (3 - 5) years of experience in clinical biostatistical and data reporting with a focus on analysis and reporting of clinical data.
- Experience with statistical methodologies, and data validation, and mining techniques.
- Strong knowledge and experience of various clinical trial designs.
- Thorough understanding of clinical data models and safety and efficacy domains in clinical trials.
- Prior experience in therapeutic areas of Oncology, Inflammation, Infectious Disease, and CNS is strongly preferred.
- Thorough understanding of the drug development process, clinical trial reporting processes, and experience of data component of drug submission is a plus.
- Good understanding of ICH guidelines, Good Clinical Practices (GCPs), and 21 CFR part 11 as these relate to the statistical reporting.
- Prior experience of drug submission or representation in meetings with regulatory authorities is strongly preferred.
- Strong experience of safety and efficacy reporting. Understanding of clinical data life cycle from data collection to submission.
- Understanding, knowledge and experience of CDISC data standards and models.
- Excellent communication, time management, and problem solving skills.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Arvind Thirumalaisamy

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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Branch: IT & Telecom