Biostatistician - San Diego, CA | Biospace
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Biostatistician

Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
8/28/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Biostatistics, Pharmaceutical,

Job Description

PRIMARY OBJECTIVE OF THE POSITION:
The primary objective of the Biostatistician is to provide statistical expertise in the design and analysis of clinical studies, as well as the interpretation and reporting of the results.

MAJOR RESPONSIBILITIES AND DUTIES:
Biostatistician responsibilities include, but are not limited to:
•   Review of case report forms, annotated case report forms and database documentation to ensure that SAS datasets will be consistent with trial design
•   Perform sample size calculations and write/review the statistical methodology section for clinical study protocols
•   Generate study randomization plans and schedules
•   Write statistical analysis plans (SAPs)
•   Generate database listings for database QA audits
•   Write SAS programs for statistical analyses, summary tables, figures and listings.
•   Perform statistical analyses of data and interpret results to ensure validity of conclusions
•   Provide final tables, listings and figures for clinical study reports.
•   Interact with the medical writer in the production, review  and approval of integrated clinical study reports
•   Interact with members of the Clinical Development Team to ensure a high level of client satisfaction through the successful execution of projects
•   Participate in Clinical Development Team meetings and also client meetings when needed
•   Participate in departmental infrastructure building; experience developing and implementing programing standards/best practices, developing and maintaining SAS macro and program libraries, and managing/forecasting workload with the ability to prioritize work to support multiple trials

Requirements

EDUCATION AND EXPERIENCE:
The candidate should have a masters or doctoral level degree in statistics with at least 3 years of experience performing statistical analysis and reporting for clinical trials.

QUALIFICATIONS:
A thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential.  Excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.   Computer proficiency and SAS programming skills are required.  Understanding of SDTM and ADaM standards.  Ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.