BACKROUND:
Scios Inc. is a biopharmaceutical company engaged in the discovery, development, and commercialization of novel human therapeutics. Our R&D efforts focus on the treatment of acute illnesses, primarily in the area of cardio-renal disease.

RESPONSIBILITIES:
Responsible for all statistical activities and support related to a disease area or clinical project. Work on innovative study designs and state of the art statistical analysis with clinicians and other project team members from various functional groups. Review protocols and case report forms for soundness of trial design, and write and develop the statistical methodology for the protocol. Review validation checks, prepare analysis plans, analyze data, prepare the statistical section of the clinical study report and review the remainder of the report, and provide statistical support for any presentations and publications. Specific job responsibilities include, but are not limited to, the following:

· Develop, implement, document and validate statistical analysis and reporting procedures to comply with all relevant FDA regulations, ICH Guidance, EMEA directives and GCP standards including preparation and maintenance of relevant Standard Operating Procedures.
· Develop appropriate statistical design and analysis plans, including sample size estimation, for inclusion in clinical trials protocols. Review and approve protocols for statistical content.
· Provide the statistical analysis for, and the composition of statistical sections of study reports for, all submissions; ensure that critical timelines are met by assuring not only timely but also accurate and valid analyses of data.
· Provide the necessary input for productive collaboration with Clinical Operations and Data Management to optimize efforts to establish and maintain all clinical databases; review case report form design, and help optimize activities relating to data management.
· Provide support and interface with SAS programmers. Good knowledge of SAS is required. Knowledge of other statistical software is a plus.
· Provide statistical support as needed for reports required by the Data Safety Monitoring and Clinical Events Committees.
· Continue to develop professional and technical expertise through attendance at professional meetings and review of published literature; this also includes keeping abreast with the FDA/Regulatory Agencies thinking and requirements in study design and statistical analyses.


REQUIREMENTS:
A PhD is Biostatistics is required. Strong project management and leadership skills, knowledge of FDA statistical guidelines and the ability to manage multiple projects simultaneously is necessary. Experience in the cardiovascular area is preferred.
Senior Biostatistician - In addition to the description and requirements above, you will manage and execute project activities and be responsible for guiding and/or consulting with senior management. Additionally, you will oversee and
guide SAS programmers in the preparation of data displays, graphs, and summary tables. You will also manage and guide CROs for statistical activities related to clinical studies as well as actively participate in Clinical Trial Teams, and in activities organized to improve operational and statistical analysis procedures. You may also be responsible for the following:

· Attend meetings and participate in conference calls with regulatory agencies; presentation of statistical analyses at meetings or during conference calls; respond to statistical questions raised by regulatory agencies.
· Provide advice and support as requested for Project Management, Marketing and Business Development

Biostatistician - 1+ years in the pharmaceutical industry or related fields.

Senior Biostatistician - 2-4 years in the pharmaceutical industry or related fields.
A Ph.D. Biostatistics is required. Strong project management and leadership skills, knowledge of FDA statistical guidelines and the ability to manage multiple projects simultaneously is necessary. Experience in the cardiovascular area is preferred.
Senior Biostatistician - In addition to the description and requirements above, you will manage and execute project activities and be responsible for guiding and/or consulting with senior management. Additionally, you will oversee and guide SAS programmers in the preparation of data displays, graphs, and summary tables. You will also manage and guide CROs for statistical activities related to clinical studies as well as actively participate in Clinical Trial Teams, and in activities organized to improve operational and statistical analysis procedures. You may also be responsible for the following:

· Attend meetings and participate in conference calls with regulatory agencies; presentation of statistical analyses at meetings or during conference calls; respond to statistical questions raised by regulatory agencies.
· Provide advice and support as requested for Project Management, Marketing and Business Development

Biostatistician - 1+ years in the pharmaceutical industry or related fields.

Senior Biostatistician - 2-4 years in the pharmaceutical industry or related fields.

HOW TO APPLY:
All interested applicants please submit your resume to the following:

Linda Brown
Talent Acquisition Consultant
Scios Inc.
6500 Paseo Padre Parkway
Fremont, California 94555
direct: 510 248-2956
fax: 510 248-2662