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| Job Title: |
Senior Biostatistician |
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Job Location:
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Raleigh - North Carolina - USA |
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Job Category:
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Statistics
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Job description:
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Works independently on clinical trial projects sponsored by pharmaceutical,
biotechnology, or medical device companies. Explains, interprets, utilizes
complex statistical procedures, and acts as mentor and technical expert to
junior biostatisticians and programming staff. Works closely with project
managers, database managers, and clinical data managers, and participates as
a project team member. Responsible for reviewing sponsors’ protocol,
providing input to study design, and developing the statistical section of the
protocol, calculating sample size, and reviewing the case report form (CRF).
Discusses statistical aspects of studies with investigators and regulatory
authorities. Estimates resources and timelines in the proposed process.
ESSENTIAL JOB FUNCTIONS:
1. Leads the planning and implementation of statistical analysis for clinical study
reports and regulatory dossiers.
2. Provides leadership, quality review, and mentoring to less experienced
biostatisticians and coordinates the work of other biostatisticians.
3. Represents company at internal and sponsor technical meetings.
4. Utilizes advanced statistical methods (interim analysis stopping rules, analysis
of pharmacokinetic parameters, logistic regression etc.).
Sr. Biostatistician
Job Code(s): SBIOS0607BP
Location(s): North Carolina, Raleigh
Region(s): North America
Date Posted: 05/06/2008
POSITION SUMMARY:
Works independently on clinical trial projects sponsored by pharmaceutical,
biotechnology, or medical device companies. Explains, interprets, utilizes
complex statistical procedures, and acts as mentor and technical expert to
junior biostatisticians and programming staff. Works closely with project
managers, database managers, and clinical data managers, and participates as
a project team member. Responsible for reviewing sponsors’ protocol,
providing input to study design, and developing the statistical section of the
protocol, calculating sample size, and reviewing the case report form (CRF).
Discusses statistical aspects of studies with investigators and regulatory
authorities. Estimates resources and timelines in the proposed process.
ESSENTIAL JOB FUNCTIONS:
1. Leads the planning and implementation of statistical analysis for clinical study
reports and regulatory dossiers.
2. Provides leadership, quality review, and mentoring to less experienced
biostatisticians and coordinates the work of other biostatisticians.
3. Represents company at internal and sponsor technical meetings.
4. Utilizes advanced statistical methods (interim analysis stopping rules, analysis
of pharmacokinetic parameters, logistic regression etc.).
5. Ensures that all work is accomplished on time and according to established
process and seeks continuous improvement of the process.
6. Employs knowledge of SAS statistical programming technique as applied to
clinical trials, while keeping up-to-date on developing SAS procedures.
7. Writes statistical sections for protocols, protocol analysis plans, mock tables
shells and finalizes clinical/statistical integrated reports.
8. Maintains overall awareness in the field of biostatistics by reading related
literature, attending training classes, attending professional meetings, etc.
OTHER RESPONSIBILITIES:
Performs other work related duties as assigned. Moderate travel may be
required (up to 50%).
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Skills:
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Requires Ph.D. in Biostatistics/Mathematical Statistics plus approximately 2
years of clinical trials experience in a contract research organization (CRO),
biotechnology or pharmaceutical environment; or a M.S. in
Biostatistics/Mathematical Statistics with at least 4 years of relevant CRO,
biotechnology or pharmaceutical experience. Requires extensive use of
independent judgment and leadership skills. Strong SAS programming skills
and experience in UNIX or personal computer environment are essential.
Strong computer skills in Microsoft Office Suite are necessary. Ability to
handle multiple tasks to meet deadlines in a dynamic environment is essential.
Requires strong organizational, presentation, documentation and interpersonal
skills as well as a team-oriented approach. |
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Masters |
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Experience (year):
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2 |
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Post Date:
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09/07/2008 |
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| Contact Information |
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Address:
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<a href="http://trials.in.ua">clinical research</a> 01033 - Ukraine |
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