Senior Manager, Biostatistics

Bracco Medical Technologies•Princeton, NJ

About The Position

Bracco Diagnostics Inc. is a subsidiary of Bracco Imaging which is part of the overall Bracco Group. The Company specializes in the clinical development, marketing and sales of diagnostic contrast imaging agents. Bracco Diagnostics Inc. primarily markets its products to hospitals throughout the United States. Bracco Diagnostics Inc. is committed to the discovery, development, manufacturing and marketing of imaging agents and solutions aimed at providing a better use and management in terms of diagnostic efficacy, patient safety and cost effectiveness. Responsible for biostatistical design, analysis, and reporting for regulatory submissions, using SAS and CDISC standards; manages vendors and performs hands-on statistical analyses to support product development and maintenance. Job Purpose The Senior Manager Biostatistics will be responsible for the design, analysis, and clear presentation of results to domestic and international regulatory submissions, and the maintenance and growth of existing products. Position requires high level of technical strength in Biostatistics, ability to do SAS programming, sound knowledge of CDISC and regulatory guidelines, and excellent verbal and written communication skills. Work would also entail Vendor management, as well as doing hands on analysis for work performed in-house.

Requirements

Statistical training/background
Very strong programming skills (SAS)
Excellent experience in CDISC
Experience in NDA submissions
High level interpersonal skills to interact effectively within team and matrix work settings.
Sensitivity to cultural differences.
Ability to organize and prioritize multiple projects simultaneously and independently.
Excellent written/oral communication skills.
Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
Ability to think clearly, be customer focused, get appropriate input from different disciplines as needed, provide focused answers.
Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, accountable, with proven analytical and problem solving abilities.
Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task.
Ability to work independently, with minimum supervision.

Responsibilities

Provide statistical methodology/sample size section of protocol
Participate in discussion of study design, active review of protocol
Provide input for development of CRFs, eCRF/specification and blinded read offsite methodology.
Manage randomization schedule
Coordinate/Manage development of Statistical Analysis Plans
Coordinate/manage timely deliverables of CDISC package and TLFs of high quality
Perform programming/statistical analysis (exploratory as well as formal, as needed)
Ensures accuracy of databases, statistical reports, and analyses
Coordinate/manage/review statistical contribution for the Clinical Study Report (statistical Methods, efficacy results section)
Prepare statistical NDA sections and review relevant regulatory documents
Collaborate and manage integration of databases for Integrated Safety and Efficacy output.
Interact effectively with FDA/EMA and other regulatory agencies, as needed
Assist in the publication support, perform analyses as required.
Assist in development of RFP, vendor selection, finalization of contract.
Assist in management of vendor support
Maintain frequent/effective dialogue with the vendor to ensure timely deliverables
Budget Management (managing activities to minimize out-of-scope work)
Communicate all relevant information effectively (both internally and with vendor team)
Manage the electronic and hard copy filing of essential documentation.
Ensure that standard operating procedures are followed
Any other duties relevant to this post that may arise