Purpose of the Position:
- Develop statistical approaches for optimal experimental design, devise sampling techniques, make sample size determinations to support product development, clinical trials, and regulatory activities
- Develop statistical analysis plans for validation studies in support of FDA submissions
- Determine the appropriate study designs, analysis plans and acceptance criteria to assess analytical and clinical performance of new products, in support of regulatory submissions
- Ensure activities are consistent with project critical path, and respond appropriately to changing priorities. Manage activities and assigned projects to reach agreed objectives.
- Work closely with team members in a collaborative environment.
- Develop work plans and approaches to deliver results as efficiently as possible.
- Adjust work schedule meet time-sensitive project milestones.
Measures of Contribution/Impact:
Contribution is measured through, but not limited to, timely achievement of program milestones, successful regulatory agency clearances.
M.S in Biostatistics or Statistics (Ph.D. preferred)
- 5+ years of relevant industry experience, preferably in an in-vitro diagnostics or pharmaceutical company and working with the FDA.
Key knowledge includes:
- Proficiency with R and SAS
- Understanding of CLSI guidance documents
- Working knowledge of biology and in vitro diagnostic tests
- Good understanding of regulatory requirements & clinical trial design
Key skills/abilities include:
- Excellent analytical skills
- Strong programming skills
- Proactive, results-oriented
- Knowledge of and ability to learn relevant clinical background and biomarker biology and incorporate these into statistical design, analysis & interpretation
- Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
- Excellent verbal and written communication skills and the ability to explain analysis in a clear, concise, accurate manner.
- Demonstrated ability to identify, evaluate, and solve problems.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
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.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Limited travel is required.