Job Description

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

Summarized Purpose:

Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical methodologies. Performs project management functions relating to the administrative and scientific

activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defenses. Organizes

teams and implements strategies to ensure process and programming efficiencies on complex studies.

Essential Functions

• Ensures compliance with the activities outlined in the department's SOPs and

contribute changes as needed. Follows departmental procedures for statistical

analyses and programming work.

• Work independently as a project lead or as lead statistician to deliver on lead

tasks/responsibilities across challenging projects; provides senior review on

projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.

• Reviews sample size calculations and protocols for completeness,

appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related

documentation.

• Writes / reviews analysis plans and guide others on the team in its

implementation. Defines appropriate methods and procedures for statistical

analysis. Reviews statistical analysis for key efficacy endpoints.

• Reviews specifications for analysis database, oversees its development, and

assures completeness for use in all programming. Oversees collaboration with

programmers and data management personnel as to database maintenance,

updating, and documentation. Supervises creation of table and listing

specifications.

• Prepares reports, manuscripts, and other documents. Contributes statistical

methods section for Integrated Clinical and Statistical Report, Integrated

Summaries of Safety, Integrated Summaries of Efficacy, and other documents.

• Monitors project budget as it relates to project work scope and communicate

proactively with management concerning potential changes in work scope.

Communicates with sponsors concerning project work scope and budgetary

changes after reviewing with management.

• Mentors members of the department by providing project guidance and

statistical advice and by promoting employee development, contributing to performance planning, and providing resource planning.

• Provides input on hiring recommendations, department policies, and resourcing requirements.
• Acts as representative of the department to other divisions. Assists in bidding

and business development activities. Consults with business development with

respect to bids and timelines.

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’). Master's degree in statistics, biostatistics, mathematics or related field.

Knowledge, Skills and Abilities:

• Comprehensive SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH)
• Capable of directing and promoting teamwork in a multi-disciplinary team setting
• Capable of reviewing current processes and identify potential process improvements
• Comprehensive understanding of a wide variety of clinical trials/designs and corresponding reporting

of data

• In-depth understanding of interpreting the results from statistical analyses of complex data
• Strong project management skills, as shown through management of multiple projects
• Demonstrated initiative and motivation
• Excellent written and verbal communications skills, including proficiency in the English language
• Substantial organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other department

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work

schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions

with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance