Proclinical is currently recruiting for a Director of Clinical Data Management with a biotechnology company located in San Diego, CA. Successful candidate will participate in designing clinical studies, assist in protocol development, review study protocols, contribute to and review data management documents, oversee statistical analysis activities, create and/or review statistical analysis documents, SAPs, assist in CSR development and/or review CSR, contribute to Data Management Plans.
Job Responsibilities:
- Demonstrate practical understanding and recognition of statistical concepts and methodologies.
- Provide statistical support for design, analysis, and reporting of clinical, nonclinical or pharmacokinetic trials.
- Develop statistical methods sections for routine studies and, with supervision, for non-routine studies, and ensure alignment with analyses as conducted.
- Contribute to decision making on study design and data collection, and, with supervision, ensure appropriateness to support study objectives.
- Work collaboratively with others to develop quality protocols, CRFs, databases, reports, and publications per agreed timelines.
- Responsible for sample size calculations for routine studies. Calculate sample size for non-routine studies with supervision.
- Determine statistical methods for routine studies, and ensure statistical methods adequately address study objectives.
- Identify and recommend corrections for flaws in scientific logic and statistical interpretation.
- Contribute to statistical methodology for non-routine studies. Provide statistical insight into the development of report strategy and assist in ensuring consistency among reports within a project.
- Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies. Develop statistical analysis plans (SAPs) for routine studies and, with supervision, for non-routine studies, ensure consistency.
- Provide accurate and timely responses to routine requests from clients and independently pursue analyses suggested by the data. Responsible for developing and maintaining good client relationships. Identify and report on data issues or violation of statistical assumptions that could affect the validity or sensitivity of planned analyses. Recommend alternative analysis strategies to address data issues or violation of statistical assumptions.
Skills and Requirements:
- Theoretical knowledge typically achieved through a related post-graduate college experience, such as a PhD degree in Statistics or a related field.
- 5-8 years of statistics experience in the pharmaceutical or related industry.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#LI-NA1
#ClinicalResearch
.png)
