Scientific Search
United States, Berwyn
Sep 2012
This job posting expired on November 13, 2012.
This position will be supporting numerous programs related to infectious disease. Initially this position will report to the Chief Medical Officer and will work closely with clinical teams on clinical development plans; the design and conduct of clinical studies; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA. This individual will need to work extensively with outside consultants.
: Familiar with all standard and evolving statistical requirements for the development of anti-infectives.
: Additional experience in epidemiology, prevention endpoints, outcomes research, and pharmacoeconomic analyses a real plus.
: Collaborates in the preparation and review of clinical development plans, provides statistically sound experimental design and data analysis input to meet project objectives and FDA statistical requirements.
: Reviews all project protocols, authors protocol statistical analysis sections, and generates study randomization.
: Reviews case report forms to ensure that protocol objectives are met and project standards are maintained.
: Assumes statistical responsibility for major segments of a project, e.g. integrated safety/efficacy section of an NDA.
: Develop statistical analysis plan (SAP), create TLG template and derived analysis datasets specification, perform QC of TLG.
: Develops statistical programs as necessary to perform analyses and prepare data displays
: Authors results sections of the clinical study report.
: Provides support for publication of clinical trial results.
: Represents company at FDA meetings.
: Supplies statistical input for regulatory submissions and in response to FDA questions and for statistical content of presentations at Advisory Committee Meetings.
: Sound understanding of regulatory guidelines in a pharmaceutical research setting.
: Develop protocols especially for statistical section and support clinical trial design
: Participate in study related activities and provide statistical support such as safety review, interim analyses for Phase II and III infectious disease, oncology care studies, etc.
: Contribute to CRF development and review edit check specification.
: Develop Data Monitoring Standards and create mock TLG for interim review
: Review data transfer plan.

: Minimum of 4 years experience in biostatistics in clinical research.
: Must have PhD.
: Infectious disease experience is highly preferred (experience with ID end points).
: Good communication skills and team collaboration.
: Familiar with statistical requirements for ex-U.S. analyses/submissions.
: Excellent programming skill in SAS.
: Team work attitude.
: Able to handle multiple projects concurrently.

For immediate consideration please email resume as a Word attachment to Alex Rogers,