Senior Biostatistician
Senior Biostatistician
Green Key Resources
Princeton, NJ
See who Green Key Resources has hired for this role
Green Key Resources provided pay range
This range is provided by Green Key Resources. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$65.00/hr - $80.00/hr
Duties
- Serving as Study Statistician responsible for the development of statistical strategies, operational executions, and statistical aspects of assigned projects and studies.
- Contributing to clinical trial design, the statistical sections of study protocols, and developing and authoring Statistical Analysis Plans (SAPs).
- Overseeing CRO activities, providing clear and explicit guidance in the development and finalization of TLF shells and TLF final productions.
- Managing timelines, reviewing and verifying all deliverables, and validating primary and key analyses of the clinical study reports (CSRs) to ensure that the statistical deliverables are of high quality and compliant with Akros' SOPs and standards.
- Responsible for the statistical interpretation of data and analysis results, ensuring proper incorporation in the clinical study reports
- 30% Contribute to study design, develop statistical sections of study protocol, develop statistical analysis plan and analysis results, provide statistical consultation to clinical study team
- 20% Review and contribute to the development of study related documents/activities: protocol, CRF, database setup, data cleaning plan, clinical study report, etc.
- 20% Participate in statistical vendor selection, manage and monitor vendor activities and deliverables, review and QC the statistical output, manage and maintain the final statistical output transferred from venders
- 5% Participate in study management with project leader and study team members to ensure adherence to timelines
- 5% Contribute to the development and maintenance of standardization, process improvement, and standard operating procedures
- 10% Maintain up-to date knowledge in the application of statistical methods and the regulatory requirements in drug development
- 5% Develop and maintain in-depth knowledge regarding disease and drug mechanism of the medical specialty areas that are assigned.
- 5% Maintain and update the knowledge of the requirement of regulatory agencies for the therapeutic areas.
- 5 years of experience in Biostatistics in the pharmaceutical industry with a master’s degree. 3 years of experience in the pharmaceutical industry with a PhD Degree.
- Understanding of common statistical models and methods, and experienced with their applications in clinical trials, proficiency in SAS.
- Must have strong written and oral communication skills. Has the ability to work with both technical and non-technical people
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Research, Analyst, and Information Technology -
Industries
Staffing and Recruiting
Referrals increase your chances of interviewing at Green Key Resources by 2x
See who you knowGet notified about new Senior Biostatistician jobs in Princeton, NJ.
Sign in to create job alertSimilar jobs
People also viewed
-
Data Entry Analyst
Data Entry Analyst
-
TPRM Data Entry Analyst
TPRM Data Entry Analyst
-
Data Analyst
Data Analyst
-
Analytics and Reporting - Data Analyst Data Analyst
Analytics and Reporting - Data Analyst Data Analyst
-
Healthcare Data Analyst - Remote
Healthcare Data Analyst - Remote
-
Data Analysis/Risk Governance: GA, TX, Pennington
Data Analysis/Risk Governance: GA, TX, Pennington
-
Financial Data Analyst
Financial Data Analyst
-
Data Entry Analyst
Data Entry Analyst
-
Data Analyst- Pennington NJ
Data Analyst- Pennington NJ
-
Data Analyst
Data Analyst
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More