Position Summary:
My client is looking for a Senior Statistician with a very high level of experience ideally within a CRO environment involving device and pharmaceutical studies. In addition to being an excellent statistician and capable SAS programmer the ability to function and communicate in a fast paced environment is required. The position requires a high level of project management and communication skills. You will be expected to demonstrate effective interaction with both clients and company personnel to resolve project issues.
The Senior Statistician reports to the Biostatistics Manager.
Responsibilities/Tasks:
Senior Biostatistician Tasks:
Statistical Lead
• Serve as lead statistician and primary client contact.
• Oversee all assigned projects and work activities.
• Provide estimates of work.
• Complete work orders as required.
Biostatistician II Tasks:
Statistical
• Review and generate specifications for datasets.
• Review dataset programming.
• Complete all necessary project documentation.
• Serve as statistical lead on projects as requested.
Biostatistician I Tasks:
Statistical
• Review study protocols.
• Participate in project related activities.
• Work under the direction of a senior level biostatistician.
• Perform Sample Size Calculations as directed.
• Create a draft Statistical Analysis Plan (SAP).
• Create draft table, listing, and figure specifications.
Programming
• Work on statistical programming tasks as directed.
• Perform initial and validation programming.
Quality Control/Quality Assurance
• Perform manual quality control (MQC) review of table, listing, and figure packages.
• Assist with other quality checks as directed.
• Complete project documentation as required.
Education/Experience Requirements:
• Master’s Degree in Statistics or related field.
• 5-10 years experience working for a CRO, Pharmaceutical, Biotech or Medical Device company.
Required Skills:
• Working knowledge of company Standard Operating Procedures (SOPs) and practices.
• Good SAS programming skills.
• Computer proficiency including Microsoft Word and Microsoft Excel.
• Ability to work in a fast-paced, team-oriented environment.
• Excellent oral and written communication skills.
• Strong attention to detail.
• Ability to understand detailed directions.
• Ability to read and interpret common scientific and technical journals.
• Ability to review statistical material for quality.
• Knowledge of FDA statistical guidelines.
• Knowledge of clinical trials.
• Knowledge of statistical methodology.
• Ability to interpret results of data analyses to ensure validity of conclusions.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Excellent time and resource management skills.
• Ability to establish and adhere to deadlines.
If you are interested in this position and would like further information, please contact me directly at [log in to unmask]
Thank you.
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