Manager/Senior Manager

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.

Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.



Position Description:

Implement and execute methodological and statistical aspects of clinical studies under the guidance of Therapeutic Area head and prject Lead Statistician according to the global project strategies.

Duties and Responsibilities
- Provide support to the study team on all statistical matters according to the global project strategies. Provide input to the Clinical Development Plan. In particular, provide expertise on local standards and requirements for the collection, analysis, and presentation of clinical data.
- Under the guidance of the Lead Statistician, work with the Study Manager in preparing the study protocol and any necessary amendments; provide advice on study design including identification of clinical endpoints; prepare statistical methodology section of protocol following global standards; prepare the randomization plan.
- Assist in designing the Case Report Forms using available global standards. Assist in preparing the data validation plan.
- Under the guidance of the Lead Statistician, prepare Study Statistical Analysis Plan. Design all data presentations including summary tables, graphs, and subject listings.
- Monitor data quality during study conduct. Proactively provide study updates; quickly provide information regarding issues along with proposed solutions.
- Perform and/or coordinate and oversee the preparation, execution, reporting and documentation of the analyses (interim and final).
- Prepare the study report together with the study team. Responsible with the Study Manager for determining the precise conclusions that a study will support. Responsible for quality and statistical integrity of study report.
- Perform analyses and prepare data presentations for clinical registration dossiers based on strategies developed by the global project team.
- Participate in planning resource and budget needs.

Supervisory Responsiblities
- Mentor and provide guidance to junior statisticians and/or SAS programmers, if appropriate

To Apply Visit Sanofi Aventis

Qualifications:

Knowledge and Skills
- Knowledge of pharmaceutical clinical development and ability to apply technical principles, theories and concepts to clinical drug development.
- Understanding of the regulatory drug submissions and approval process at the regional level.
- Understanding of statistical concepts and techniques and of clinical trial principles.
- Demonstrated teamwork, and interpersonal skills.
-Excellent verbal, written and presentation skills.
- Experience in SAS programming.
- Experience managing projects and/or CROs desirable.

Formal Education/Experience
- Ph.D. or MS in statistics or closely related field.
- A minimum of 3 years of clinical research experiences in pharmaceutical industry for a Ph.D. candidate.
- A candidate with MS in statistics or closely related field and 2 more years of pharmaceutical experiences will also be considered.