The position is responsible for the design, analysis, interpretation and reporting of non-registrational clinical trials, including Phase IIIb IV trials, investigator INDs, and clinical grants. A key responsibility and function will be exploratory data analyses, including data mining of primary and secondary data sources, leading to the publication of manuscripts, abstracts, and hypothesis generating outcomes relevant to the goals and objectives of the Business Unit. The candidate should be very skilled at translating abstract ideas into analyzable questions and hypotheses in addition to communicating and interpreting the results to a non-quantitative audience. The individual will be very hands-on with an excellent statistical background and experience including proficient programming skills. Experience with S-PLUS would be highly desirable. Excellent oral and written communication skills are required along with an ability to effectively interface across company wide Departments as well as experience in the management of outside CROs, consultants and contractors. This position may be responsible for the supervision of solid line and or dotted line statisticians and statistical programmers. Experience with direct supervision is required for the Managerial track. With Master''s degree: 5 to 7+ years of biostatistical experience, which includes 4 to 6+ years of relevant pharmaceutical experience, 3 to 4+ years of relevant programming experience, 1+ year of experience in the management of external technical resources, and 1 to 2+ years of experience with regulatory contacts. With PhD: 4 to 6+ years of biostatistical experience, which includes 4 to 6+ years of relevant pharmaceutical experience, 3 to 4+ years of relevant programming experience, 1+ year of experience in the management of external technical resources, and 1 to 2+ years of experience with regulatory contacts. Experience with direct supervision is desirable. NECESSARY SKILLS: Communication - presentation, oral, and written communication skills required and demonstrated at a fully proficient and competent level.Administrative - project management, time management, recruiting, and resourcing skills required and demonstrated at a proficient and competent level.Technical - statistical knowledge, SAS programming, statistical programming, study methods (data flow, design analysis, interpretation), clinical medical other relevant knowledge, and regulatory knowledge & contacts required and demonstrated at a fully proficient and competent level.Supervision - direction, management of external resources, and mentoring skills required and demonstrated at a proficient and competent level.COMPETENCIES: Leadership Team - leadership, influence, facilitation, assertiveness, consensus building, and interaction skills required and demonstrated at a proficient and competent level. Personal Interpersonal - judgment, discretion, accepting responsibility accountability, and self motivation initiative skills required and demonstrated at a proficient and competent level.Problem Solving Task Orientation - broad perspective, problem solving, goal oriented, process oriented, innovation, influence, and ability to research a problem and find a solution required and demonstrated at a proficient and competent level. Master''s degree in Biostatistics, Applied Statistics, or related field. PhD preferred. For more information regarding this position please send your CV to bgibbon@amgen.com. NO AGENCY'S PLEASE.

We are currently looking for a Clinical Statistician in our Cambridge MA facility. We are looking for 2-3 years of Statistical Analysis in a Biotech / Pharmaceutical environment with Phase 2 and Phase 3 clinical trial data. Experience performing Kaplan-Meier, Logistic regressions, Fisher?s exact, categorical data analysis, and Multivariate analysis. MS in Bio-Statistics or Statistics, and demonstrated SAS programming skills. Biopure Corporation is a leading developer, manufacturer and supplier of a new class of pharmaceuticals, called oxygen therapeutics, which are intravenously administered to deliver oxygen to the body's tissues as a sterile alternative to red blood cell transfusion. Biopure's oxygen therapeutics possess unique attributes that address many of the medical and logistical issues associated with red blood cell transfusions. If you or any of your associates are interested in our Cambridge, MA openings please forward a resume to jrynak@biopure.com or fax to 617-234-6505. Thank you for your interest in Biopure. John Rynak Biopure Corporation 617-234-6835

Associate Director, Biometrics I am assisting to recruit an Associate Director, Biometrics for a CRO located near Boston, Massachusetts. Do you know anyone who might be interested in this? Here is more information: The Associate Director, Biometrics oversees all Biometrics activities to ensure successful completion of projects; provides statistical/technical guidance to the biostatistics staff, and programming/technical guidance to SAS Programmers; serves as primary point of contact for project managers, line managers, executive staff, and clients. Will also: direct the creation of analysis plans and specifications, validation protocols and reports, and statistical reports; ensure project completion is timely and according to guidelines; work interdepartmentally to define Biometrics timelines and resourcing needs; monitor timeline compliance across projects for analysis plans, logic checks, data entry audits, and analyses; develop SOPs and monitor compliance; develop budget proposals; collaborate inter-departmentally to define and solve operational issues; represent clients at FDA meetings; manage personnel activities; function as Lead Biostatistician on selected projects. Qualifications: Ph.D. in Biostatistics or related discipline and 4 years of industry experience, or M.S. with a minimum of 9 years industry experience including 2 years in a CRO; minimum 3 years project and team management experience. Must also have: strong management skills and experience managing projects in a CRO environment; in-depth knowledge of the company's statistical analysis procedures; advanced computer skills; organizational, leadership, decision making, and strong communication skills. Preferred qualifications: Ph.D. in Biostatistics or related discipline; 4+ years of industry experience including 3 years experience in a CRO. Some of the benefits offered to employees include: 3 weeks paid vacation Health, Dental, Life Insurance, and Long Term Disability Insurance 401(k) Retirement Savings and Profit Sharing Plan Tuition reimbursement up to $3000 Flex Time Policy In addition, they offer a competitive salary, excellent benefits and a non-smoking environment. They are an Equal Opportunity Employer. If you are interested in pursuing this opportunity, please send cover letter and resume with salary history to resumes@workwondersstaffing.net. We do offer generous referral fees. Additional opportunities are listed on our web site: www.workwondersstaffing.net