I recommend clinical research training with

STEVE SUTTER • February 10, 2003
Opportunity: SENIOR BIOSTATSTICIAN, Clinical Research--Southern Calif.
(1 comment)
ABOUT US
Leading neuroscience company located in Southern Calfornia focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes.

RESPONSIBILITIES
This position will collaborate with Clinical Research scientists, consultants, and other biostatisticians in the development of clinical trial protocols. This includes selecting the optimal experimental designs, defining endpoints, and identifying and/or developing appropriate statistical methods of analysis for protocols developed in-house as well as by Contract Research Organizations (CROs). They will participate in the development and review of clinical trial data capture processes and media, including electronic data capture methods and paper case reports forms (CRFs). Also, ensure that all protocol-required data are collected in consistent formats that reflect any applicable standards. Review and approve data management plans and database quality control/audit plans prepared by CROs. Ensure that appropriate data edit check specifications, quality control checks, and audit procedures are implemented. Will also prepare and approve statistical analysis plans, and collaborate with CRO biostatisticians in the preparation of statistical analysis plans as necessary. Ensure that statistical analysis plans completely describe all appropriate statistical methods and provide detailed specifications for summary tables, figures, and listings. Will oversee and monitor CRO performance of biostatistics and data management tasks to ensure that timelines are met and that any resource issues are identified and resolved. Provide biostatistical support to nonclinical areas of the company, including consulting and data analysis. Assist in the development of department SOP;s, procedures and statistical analysis plan and report templates, standardization of CRFs, and selection and implementation of statistical software.

REQUIREMENTS
M.S. in Biostatistics or closely related field with at least 5 years of experience, or Ph.D. with at least 3 years of experience in the design, analysis, and reporting of Phase I to Phase III pharmaceutical clinical trials. This experience may have been obtained in the pharmaceutical industry, CROs, or FDA. Experience must include serving as Senior/Principal Project Biostatistician on one or more projects, working with CROs, and interacting with FDA. Strong SAS skills required, and a thorough understanding of data management processes is essential. Excellent oral and written communication skills are required.
COMPENSATION & COMPENSATION

Salary $110,000 plus Stock Options.

HMO (Paid by Company) or PPO (Shared cost by employee) for family.

Flexible work schedule with core hours from 9:00 am - 4:00 pm.

Three weeks of paid vacation each year.

11 paid holidays including the workdays between December 25 and January 1.

On-site workout room.

Contact Steve Sutter:
http://bioinformatics.org/sendmessage.php?touser=7011