Summarized Purpose : Performs 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.
Functions as Biostatistics Project Leader for projects.Supports Biostatistics and Programming directly contributing to simple or moderately complex study protocols and bid defenses.
Organizes teams and implements strategies to ensure process and programming efficiencies on simple to moderately complex studies. Essential Functions :
Becomes familiar with the activities outlined in the department's Working Practice Documents and contribute changes as needed.
Learns and follows departmental procedures for statistical analyses and programming work.
Serves as a lead statistician on large and complex projects
Leads a project team. Conducts team meetings, maintains project timelines, assesses resource needs, provides resources, and budget preparation.
Ensures that SOPs are being followed and that appropriate project documentation is ongoing.
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.
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.
Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
Develops or supervises creation of table and listing specifications. Ensures that proper validation for statistical tables and listings is being implemented.
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.
Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
Understands 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.
Acts as the representative of the department to other divisions
Provides general infrastructure support to the Biostatistics Department (presents / teaches at the Bios Department meetings, contributes to other general department documents or policies, assists with Bios newsletter, helps in Bios department libraries, or trains new hires).
Provides input to the Directors, Associate Directors, and Managers as to hiring recommendations, department policies, and resourcing requirements.
Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.
Education and Experience : Master's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).
Knowledge, Skills and Abilities :
Strong SAS® programming skills
Ability to direct and promote teamwork in a multi-disciplinary team setting
Proven performance of required tasks, as evidenced in outstanding performance in current tasks and / or documented record of accomplishments
Evidence of strong management skills, as shown through management of multiple projects and / or staff members
Demonstrated initiative and motivation
Excellent written and verbal communications skills
Good organizational skills with the ability to adapt and adjust to changing priorities
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.
Requisition ID : 148776