Provides statistical support to the client including preparing analysis plans, data analysis, and statistical report writing.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

Communicates orally and in writing with clients regarding the substance of analyses and reports.

Performs statistical analysis of clinical trial data by reviewing protocols and CRFs, developing and validating SAS programs following appropriate guidelines or SOPs.

Writes statistical analysis plans and reports.

Meets with other staff members and clients for status updates and progress reports.

Implements analyses of safety and efficacy.

Provides technical support and guidance to SAS Programmer I or II, and Biostatistician I or II.

QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Doctorate degree (Ph.D.) with at least 36 credit hours in statistics or equivalent and 3 or more years experience in biomedical/pharmaceutical industry or research hospital or related experience and/or training or Master's degree (M. S.)in Statistics, or a Master's degree in a related field with at least 12 credit hours in statistics or the equivalent and 4 or more years experience in biomedical/pharmaceutical industry or research hospital or related experience and/or training or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

COMPUTER SKILLS

Solid SAS programming skills. Intermediate to advanced knowledge of business applications.

TECHNICAL SKILLS

Ability to comprehend and apply principles of advanced statistical theory. Thorough understanding of CRO industry, drug development/approval process and data management process.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

TEAM SKILLS

Ability to establish and maintain good working relationships. Exhibits tact and consideration in relations with others, a positive outlook and pleasant manner. Motivated to assist and support co-workers. Ability to work cooperatively in group situations and takes responsibility to help resolve conflicts.

CUSTOMER SERVICE

Ability to be sensitive to customers and handle most difficult customer situations. Ability to fulfill commitments made to customers within expected time frames and to respond promptly when servicing customers. Ability to use customer feedback to improve service.

CONTINUOUS LEARNING

Demonstrates a significant degree of interest in career and professional growth and appears to have a skills and abilities development plan. Has made successful efforts to diversify own skills and knowledge base.

PHYSICAL DEMANDS 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.

Must be able to operate standard office equipment. Must occasionally be able to travel to various clinical sites. While performing the duties of this job, the employee is frequently required to talk or hear. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision.

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 may encounter difficult and/or demanding customers. The noise level in the work environment is usually moderate.