Enterprise Resource Group
(6 positions)

1.) Senior Biostatistician - Clinical Studies
Location: South San Francisco, CA

Description:
Seeking a Sr. Biostatistician for a successful Biotech company in the San Francisco area. Be part of team developing new generation drugs and medical treatment. You will be responsible for portions of major clinical studies projects including statistical integrity, adequacy, and accuracy of clinical studies projects. Plan, coordinate, and provide statistical analyses, summaries and reports for product development and U.S. PLAs/NDAs. Provide appropriate statistical advice and support to the clinical directors. Adhere to standards of acceptable statistical methodology, regulatory guidelines and departmental guidelines.

Requirements:
Ph.D. in Biostatistics or related discipline with 4 plus year’s experience, or a Master's Degree in Biostatistics with 6 plus years experience in the support of clinical studies, preferably in a pharmaceutical industry or clinical studies setting. Knowledge of applied statistics and biostatistics, and relevant experience in the applications of statistics to medical trials. Experience with major statistical software packages such as SAS and S-plus. Strong interpersonal and effective communication (oral and written) skills. Experience in phase I-III clinical trials or studies in support of U.S. PLAs / NDAs.

Email resume for immediate consideration, or for further information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com

2.)Sr. Biostatistician – FDA Regulatory Reporting
Location: South San Francisco, CA

Description:
Seeking a Sr. Biostatistician for a successful Biotech company in the San Francisco area. Be part of team developing new generation drugs and medical treatment. Work with senior biostatistics and clinical development teams to design and conduct, evaluate, interpret and prepare results of clinical studies. Develop methodology for statistical analysis and generate study randomization. Determine analysis and data presentation specifications for programmer analysts and statisticians. Perform analysis, interpret study results, collaborate with medical and biostatistics staff to produce reports, and publications. Represent the biostatistics function on project teams. Interact with FDA staff to ensure drug studies meet FDA requirements. Attend meetings with FDA on project development, collaborate with medical and biostatistics staff to produce reports for the application to the FDA. This position supports the development of various medical treatments.

Requirements:
Minimum requirements: are a Ph.D. in Biostatistics or closely related discipline and at least two years experience, or a Master's Degree in Biostatistics and four years experience in the support of clinical studies, preferably in a pharmaceutical industry or clinical studies unit setting. Sol id experience in statistical experimental designs and analyses, clinical trial requirements and statistical software packages such as SAS and S-PLUS. Strong interpersonal and effective communication (oral and written) skills. Pharmaceutical or closely related industry experience. Experience with Phase I - III clinical trials or studies in support of U.S. PLAs/NDAs

Email resume for immediate consideration, or for further information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com

3.)Title: Clinical Database Administrator / Manager
Location: South San Francisco, CA

Responsibilities:
· Seeking an experienced Clinical Database Administrator to set up and run a clinical data management department. This will include hiring and supervision of data management personnel.
· Supervise all clinical database and data management activities for clinical studies and related departments.
· Responsible for the selection of a clinical database for the company.
· Work closely with the Information Systems Department on installation and support issues.
· Ensure that CRF log-in, database definition, entry, quality assurance, documentation, and storage meet regulatory requirements.
· Build and maintain a data dictionary for use in all clinical trials. Designing and implementing standard libraries.
· Coordinating the selection, installation, and maintenance of adverse event and drug thesauri.
· Ensuring CRO adherence to data dictionaries, thesauri, file structures, and variable naming and attribute conventions.
· Developing and implementing standard CRFs.
· Writing, implementing and/or specifying standard data queries and reports.
· Writing, implementing, and/or specifying quality assurance checks.
· Coordinating CRF development with other personnel.

Skills:
·Experienced in clinical database administration, including database design, validation, implementation, and documentation.
· Extensive knowledge of one or more relational databases. Knowledge of Datafax and remote data entry systems is desirable.
· Managerial experience.
· Proficiency in writing SQL queries for data validation and monitoring.
· Excellent written and verbal communication skills.
· Ability to work as part of a multi-disciplinary team.
· B.S. degree in healthcare, life science, or computer science preferred.

Email resume for immediate consideration, or for further information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com

4.)Biostatistician / Research Associate
Palo Alto, CA

Seeking someone with a PhD in Biostatistics or similar discipline, will consider a recent PhD graduate. You will work with a multidisciplinary academic team to develop cutting-edge mathematical and statistical models that describe the natural history of various types of cancer and apply these models toward analyzing cancer trends, simulating cancer screening trials, and evaluating the cost-effectiveness of new screening technologies.
The research associate will have the opportunity to exercise their creativity and initiative, to author and co-author publications or patents, as well as attending scientific meetings and to build connections with partners in the industry. Research experience in stochastic modeling, statistical inference, and biostatistics is needed. Knowledge of cancer biology is desirable.

Email resume for immediate consideration, or for further information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com

5.)Sr. SAS Programmer Analyst – Clinical Trials
Location: South San Francisco, CA

Description:
Seeking a Senior Statistical Programmer Analyst for a successful Biotech company in the San Francisco area. You will be responsible for the design, development, implementation, and maintenance of software for the monitoring, reporting, and analysis of clinical trials. Develop software to monitor ongoing studies, produce data listings, summary tables, graphics analyses and publication. Integrate data across studies; provide consistency within a project, database design, analysis files, tables, listings, and graphs. Test, document, review and validate all programs according to departmental guidelines. Review the CRF design, data management, and statistical analysis plans for impact on software systems and study analyses. Do enhancements and / or new features for applications. Develop specifications and coding for new standardized clinical software tools.

Requirements:
Minimum 4 years of SAS programming with a BS in statistics, math, or 2 years with an MS in a related field. Skilled in SAS programming language, data step programming and report writing and macro writing. Skilled in use of graphics software (SAS/Graph, S-Plus. Knowledge of advanced statistical procedures in SAS (Lifeset, Mixed, Glm). Knowledgeable in data base theory, relational database concepts and Oracle Clinical. Ability to interact effectively with members of other functional teams. A working knowledge of basic statistics for communicating effectively with biostatisticians. Some experience with data warehouse design and implementation and database design. Understanding of regulatory guidelines, SAS to process, report, and analyze clinical trial data, understanding of the drug approval process. Knowledge of regulatory filing desirable but not required.

Email resume for immediate consideration, or for further information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com

6.)Sr SAS Programmer Analyst – Regulatory Reporting
Location: South San Francisco, CA

Description:
Seeking a Senior Statistical Programmer Analyst for a successful Biotech company in the San Francisco area. You will be part of a team doing the preparation of data, data documentation, computer programs, report documents, and case report forms for electronic submission of clinical studies to the FDA. You will participle in the preparation of materials for electronic submission to the FDA, including data, data documentation, computer programs, reports and CRFs. Provide consistency across protocols on format of electronic data, programs, reports and CRFs. Work collaboratively with members of the clinical project team to proactively define deliverables, formats, and processes for electronic submissions.

Requirements:
Minimum of 4 years SAS programming with a BS in statistics, math, computer science, or 2 years experience with an MS in Statistics. Experience in SAS programming, cross-platform and cross-architecture approaches. MS-Word, Excel, Adobe/Acrobat. Familiar with database theory, concepts and Oracle Clinical. Thorough understanding of the drug approval process with extensive experiences in the support of at least one phase of drug development. Good interpersonal, written and verbal communication skills required. Ability to communicate effectively with biostatisticians. Knowledge in data warehousing, database design and implementation. Understanding of regulatory guidelines for electronic submissions.

Email resume for immediate consideration. For more information please contact:

Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) tom@eResourceGroup.com