Associate Director Non-Clinical Statistics - Teva Pharmaceuticals-Global Respiratory R&D

Position Description

The Associate Director, Nonclinical Statistics – located in Miami Florida or Horsham Pennsylvania is for a skilled scientist with training and significant experience in statistics and pharmaceutical development. This position will lead a small group responsible for providing expert statistical input and analyses for pharmaceutical development programs conducted by Global Respiratory R&D. The Associate Director, Nonclinical Statistics will manage the day-to-day work of one or two other junior nonclinical statisticians. He or she needs to be knowledgeable about statistical principles and appropriate software and tools to perform his or her tasks. The Associate Director, Nonclinical Statistics is expected to work collegially and closely with pharmaceutical development staff located in three locations (Miami, USA, Waterford, Ireland, and Haarlem, Netherlands) to provide statistical input into all relevant tasks. The Associate Director, Nonclinical Statistics is expected to attend regulatory and project meetings as appropriate to support respiratory activities. He or she must have excellent written and oral communication skills. Percentage of travel will be determined by the location of position. If based in PA at least 30% travel, if FL based 10%-20%.

• Responsible for providing statistical leadership to the pharmaceutical development organization in the areas of Quality by Design, Six Sigma, data analysis, data mining, experimental design, systems used for statistical analysis, establishing bioequivalence, determination of expiration dating, and the training of pharmaceutical development staff. • Recruits, coaches and develops organizational talent.
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Provides study design input and consultation for pharmaceutical development experiments and plans
• Leads small team of nonclinical statisticians to provide expert statistical support and analyses for the pharmaceutical development organization
• Ensures that data sets and their associated define files are prepared correctly and on time to support FDA submissions
• Leads efforts to select CROs for outsourcing of statistical activities when required
• Help develop and maintain departmental SOPs and ensure their compliance in daily work

Qualifications:
• Ph.D. in Statistics/Biostatistics (or related field) with a minimum of 6 years of related experience or MS/MA with 10 years of experience is required. • Ph.D. is preferred • Experience with pharmaceutical development of respiratory devices highly desired • Good presentation and written communications skills. • Ability to communicate with non-statisticians to interpret statistical findings • Good organizational and problem-solving skills. • Experienced in management of technical and professional teams, demonstrated leadership qualities, and creative and strategic thinking preferred. • Ability to program using SAS • Knowledge and understanding of device regulatory guidelines and perspective is preferred. • Knowledge of techniques for demonstrating bioequivalence highly desirable • Demonstrated ability to deliver quality products with efficiency as well as having relevant technical and scientific publications is preferred. • Statistical knowledge desired in the following areas  DOE / Response Surface Methodology  Variance components / hierarchical designs  General and generalized linear models  SPC / Six-Sigma  Multivariate / Predictive modeling techniques (such as PLS, MARS, Regression / Classification Trees, SVM, etc)  General probability theory  Population bioequivalence ===== Search Firm Representatives Please Read Carefully: Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.

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