Director of Biostatistics

Lead Biostatistical Efforts for Upcoming Clinical Trials.
Background: We provide help to millions of people whose immune functions have gone awry by developing drugs
to inhibit certain immune system functions that cause autoimmune, cardiovascular, and other diseases.
Publicly traded, our financials show there is a market for our products. 2002 fiscal year sales of $6.5M were
up 45% from the year prior. One lead drug candidate, developed with Procter & Gamble, targets inflammation
following cardiopulmonary bypass surgery, and another candidate targets rheumatoid arthritis and lupus. Our
work in xeno-transplantation is in concert with development of a T-cell inhibitor technology to treat
multiple sclerosis, Parkinson's disease, and other neurological disorders.

We are looking to hire a Director of Biostatistics who can work under the auspices of our drug development
and project management group. We are looking for someone who is adept at providing support for new drug

In this role you will:
*Supervise and manage statisticians and a data management group.
*Establish performance standards.
*Establish and approve SOPs for department.
*Approve all clinical protocols.
*Ensure departmental efficiency within the clinical department.
*Provide key input into company clinical and regulatory strategy.
*Take responsibility for all statistical aspects of protocols and documents used in regulatory filings and
meet with appropriate regulatory authorities.
*Provide appropriate study designs, analysis plans and study implementation.
*Review and approve clinical study reports.
*Oversee multiple interdisciplinary teams.
*Independently develop and apply statistical methodology appropriate to analysis of clinical studies
utilizing knowledge of regulatory agency/statistical guidelines.
*Provide input for phase I to phase IV studies.
*Oversee interactions with CROs.
*Represent the Clinical Development Department to the rest of the company.
*Oversee and develop the statistical and data management aspects of the department's budgets.
*Perform due diligence review for company as required. Prepare and present due diligence review of company.

We are looking for someone with a PhD in Biostatistics (or related) who has a solid seven years of bio/pharma
industry experience.
Base salary is commensurate with experience but will be market rate and competitive with industry standards.
     Send a resume in confidence to Jerry Bires, whose email is or contact me below:

Jerry Bires, Sr. Consultant
CastleRock Technology, WWW.CRTI.COM
O: 415-289-1587
M: 415-378-9041
FAX: 415-289-3788