Senior Manager, Biostatistics

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.

Main Responsibilities, Activities, Duties, and Tasks

• 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

Supervisory Responsibilities : N/A

Education

Ph.D. in Biostatistics preferred. Masters in Biostatistics with at least 10 years of relevant experience acceptable.

Professional Experience, Knowledge & Technical Skills

• 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.

Core Relationships

• Collaborate closely and effectively with Medical Leaders, clinical managers, data managers, statisticians, medical & regulatory writers, medical communication, and regulatory groups
• External Biometrics Vendor

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must be able to communicate via telephone, written correspondence, or spoken word in order to perform the essential duties of the position.