Biostatistician Job

Employer Name: RHG	SpiderID: 2892088
Location: Palo Alto, California	Date Posted: 9/15/2009
Wage:	Category: Biotech
Job Code:
Number Of Openings: 2

Job Description:
Contract Biostatistician
Principal Duties and Responsibilities
Х Responsible for statistical aspects of assigned projects, including experimental design, sample size estimation, patient randomization, case report form design, statistical analyses, and presentation of data.
Х Ensures that project-related biostatistics and programming work is carried out in accordance with SOPs. Develops study specific procedures (SSPs) for assigned projects as required and ensures that project team members adhere to the SSPs.
ХХ Directs and conducts statistical analyses and interprets results of analyses for assigned studies. Maintains consistent analytical approaches and reporting formats within and across studies.
Х Assists clinical database administrators in the design of study databases. As needed, reviews study database structures and data management coding conventions. Reviews and, when necessary, writes quality control specifications for projects.
ХХ Understands and uses SAS as well as other statistical software packages. As needed, writes programs to select, retrieve, manipulate, edit, and analyze data.
Х Responsible for the accuracy and completeness of statistical analyses conducted for assigned projects. Researches and applies new statistical procedures as needed Monitors and when needed verifies statistical analysis programs written by biostatisticians and statistical programmers.
Х Projects statistical and programming resource requirements needed to meet project timelines.
ХХ Documents and archives analysis and programming work to ensure a complete audit trail. Participates in the setting of project documentation standards. Creates and maintains biostatistics files for each assigned project.
Х Establishes and maintains effective working relationships with vendors and project team members, including data management personnel, statistical programmers, and clinical research personnel.
Х Participates as needed in project meetings, including investigator meetings.
Х Provides statistical input for regulatory submissions. Responds to statistical questions raised by regulatory agencies.

Qualifications
Х Senior Biostatistician I: Ph.D. or M.S. in statistics, biostatistics, or related field with at least 4 (Ph.D.) - 6 (M.S.) years of project biostatistician experience in the biotech/pharmaceutical industry.
Х Senior Biostatistician II: Ph.D. or M.S. in statistics, biostatistics, or related field with at least 6 (Ph.D.) - 8 (M.S.) years of project biostatistician experience in the biotech/pharmaceutical industry. Must have an in-depth knowledge of study designs and statistical analysis conventions in two or more therapeutic areas.
Х Experience with clinical study reporting, ISS/ISE requirements, and NDA submissions in paper and electronic format is essential.
Х Excellent verbal and written communication skills are required.
Х Comprehensive knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS, are a must.
Х Able to collaborate effectively with internal and external study management teams to meet project timelines.
Х Must be able to translate clinical study designs into statistical practice and educate study team members in the use of statistics
Х Good interpersonal and project management skills are important.

Thanks,
Andrew
andrew@resourcehuntgroup.com
972-968-7121

Job Requirements:
Biostatistician,

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 7
Education Required: Doctoral
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: Robert Thomas	Company Type: Staffing Agency
Company: RHG

City: Paloalto
State: California
Zip: 95005