|
|
|
|
|
|
|
|
|
 |
 |
 |
|
|
|
|
Printer friendly  |
| Job Title: |
Manager, Biostatistics |
|
Job Location:
|
Raleigh - North Carolina - USA |
|
Job Category:
|
Statistics
|
|
Job description:
|
Leads, manages and supports the Biostatistics team in all project deliverable tasks including project timelines, resourcing, and budgetary planning. Supervises Biostatistics staff. Assists in the development and refinement of existing departmental processes.
ESSENTIAL JOB FUNCTIONS:
1. Line management of staff including: performance management, progressive discipline, and training need identification. Recommends courses of action on salary administration, transfers, new hires, terminations, and professional development. Regularly communicates with staff on working practices, policies, and work instructions. May develop internal training in new technology and industry methods. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals to increase knowledge and skill levels and by delegating tasks commensurate with skill level.
2. Assists with developing, monitoring, and enforcing productivity and quality standards. Assists with project and timeline metrics and monitoring.
3. As a senior member of the Biostatistics department, provides senior review of outgoing deliverables and creation or review of setup specifications.
4. Interacts with and serves on project teams. Coordinates and leads development activities for projects. Accepts unique and new assignments, works independently and completes work on time. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
5. Builds positive departmental and inter-departmental relationships. Provides leadership, training, guidance and support to other department members.
6. Involved in other company activities where statistical services are required, such as global and full development programs.
7. Provides scientific consulting in the design of drug development.
8. Collaborates in protocol development as required (completing statistical section of protocols). Writes and reviews protocol analysis plans and mocks table shells. Prepares and submits ICH and regulatory dossiers.
9. Processes and maintains a broad overall knowledge in the field of Biostatistics and clinical trials design / analysis by reading related literature, self-training, attending training classes, attending professional meetings, and assists in the development of new initiatives for technical enhancements and process improvements.
Minimal travel may be required (up to 25%). |
|
Skills:
|
Requires a Statistics, Ph.D. degree in Biostatistics plus 5 years experience with a minimum of 3 years design and analysis of clinical trials experience in a Contract Research Organization or Pharmaceutical/Biotechnology company, or a Masters degree in Biostatistics/Statistics with 6 years experience. Experience with preparation and submission of ICH and regulatory dossiers required. Requires in-depth knowledge and application of FDA regulations. Experience in therapeutic specialties of Company preferred.
Working knowledge of a major statistical software program, e.g., SAS is necessary. Experience with other statistical software such as, StatXact, Nonlin and EaSt is preferred. Data management experience is preferred. Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments.
Evidence of management experience and demonstrated leadership skills are required and demonstrated by previous management of multiple projects and staff members. Excellent written and verbal communications skills essential. Good organizational skills with the ability to adapt and adjust to changing priorities. Requires positive attitude and the ability to work well with others. Strong computer skills in Microsoft Office Suite are necessary. |
|
Employment type:
|
|
|
Salary Range:
|
Unspecified |
| |
| Other Information |
|
|
| |
|
Degree:
|
Doctorate |
|
Experience (year):
|
5 |
|
Post Date:
|
09/07/2008 |
| |
| Contact Information |
|
|
| |
|
Address:
|
<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
| |
|
|
 |
 |
 |
|
