Job Description

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Responsibility:

• Functions independently as a project lead or lead statistician to deliver the project tasks responsibilities.
• Performs project management functions relating to the administrative and scientific activities of specific project work and team members.
• Oversees statistical aspects in the design and analysis of clinical trials including project management statistical analysis report preparation and advising other project statisticians.
• Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses including organizing teams and implementing strategies to ensure process and programming efficiencies.
• Ensures compliance with the activities outlined in the departments.
• Working Practice Documents and contributes 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 large and complex projects Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
• Provides sample size calculations and review protocols for completeness appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.
• Provides randomization schemes and appropriate documentation Writes reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. Provides specifications for analysis database oversee its development and assures completeness for use in all programming.
• Coordinates with programmers and data management personnel as to database maintenance updating and documentation.
• Performs statistical analysis for key efficacy endpoints. 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 completing performance planning and providing resource planning.
• Provides general infrastructure support to the Department presents teaches at the department meetings contributes to other general department documents or policies assists with newsletter helps in department libraries or trains new hires.
• Acts as the representative of the department to other divisions Assists in bidding and business development activities Consults with business development with respect to bids and timelines.

Experience:

• Previous experience that provides the knowledge skills and abilities to perform the job comparable to 3 years. Masters degree in statistics biostatistics mathematics or related field Strong SAS programming skills. Proficient in BASE STAT MACRO and GRAPH and understanding of database structures Capable of directing and promoting teamwork in a multidisciplinary team.
• Setting Strong understanding of statistical principles and strong statistical skills Solid project management skills as shown through management of multiple projects.
• Demonstrated initiative and motivation Strong written and verbal communications skills including proficiency in the English language Strong 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 departments A seasoned experienced professional with a full understanding of area of specialization resolves a wide range of issues in creative ways.
• This job is the fully qualified career oriented journey level position Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors Normally receives little instruction on day to day work general instructions on new assignments.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions Represents the department as a prime contact on projects Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.
• Networks with senior internal and external personnel in own area of expertise No management responsibility

Work 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 Frequently stationary for 6 to 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 1520 lbs.
• Ability to access and use a variety of computer software developed both inhouse 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 multitask Regular and consistent attendance