Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
Job Description
Responsible for the bioinformatics programming aspects of clinical trials from design through analysis and
reporting.Acts as a key contact for client interactions and bid defenses, or internal contact for large
technical initiatives, and ensures effective delivery across all project requirements including
communicating priorities and work direction to complete assigned tasks on time and within budget.
Oversees the resourcing of studies, or technical initiatives, and develops programming strategies and
timelines to ensure process and programming efficiencies.
Essential Functions and Other Job Information:
Essential
Functions
• Reviews and ensures adherence to departmental working practice documents
and SOPs, and contributes to their development.
• Works to increase the visibility of the company by encouraging and actively
contributing to the publications of articles in industry journals and presentations
at conferences including contributions to indsutry advancements in clinical trial
computation methods.
• Monitors and ensures adherence to contractual obligations or limits with our
clients.
• Works directly with project team leaders and client representatives to assess and
develop project goals and timelines.
• May serve in a project lead role on selected multiple projects including NDAs,
complex programs, tool development and acting as a reviewers of key
submission materials for regulatory authorities or deployment of tools &
processes.
• May lead Investigations into technical issues related to SAS, data collection
platforms (e.g., Medidata), and the computational platforms used within the
department.
• Acts as a subject matter expert in leading or assisting efforts to conduct clinical
trial statistical analysis.
• May manage computational environments by identifying resource and equipment
requirements, conducting efficient capacity planning, and managing software
and hardware availability.
• Provides general infrastructure support to the department. Examples include
giving presentations at department meetings, contributing to documents or
policies, contributing to and/or leading process improvement initiatives,
providing technical training to teams, technical mentorship of team members
and assisting with departmental web page development.
• Provides mentorship and guidance to junior team members; assists people
managers with leadership activities, such as interviewing, job description design,
etc.
Job Complexity Works on complex issues where analysis of situations or data requires an in-depth
evaluation of variable factors.
Job Knowledge Having wide-ranging experience, uses professional concepts and company objectives
to resolve complex issues in creative and effective ways. Some barriers to entry
exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision
Received
Determines methods and procedures on new assignments and may coordinate
activities of other personnel (i.e., Team Lead). Exercises judgment in selecting
methods, techniques and evaluation criteria for obtaining results.
Business
Relationships
Frequent contacts with internal personnel and outside customer representatives at
various management levels concerning operations or scheduling of specific phases of
projects or contracts. Creates formal networks with key contacts outside own area
of expertise.
Qualifications:
Education and Experience:
MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 6
years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or
Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent
and relevant formal academic / vocational qualification, and at least 8 years of experience that provides
the knowledge, skills, and abilities to perform the job requirements.
In some cases an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
• Advanced SAS programming skills and understanding of database structures
• Solid management skills, including developing staff and their career objectives and the ability to
motivate and inspire staff
• Capable of facilitating communication with clients, project teams, departments and staff
• Solid decision making skills to decide company policies and procedures regarding programming
• Solid understanding of tracking project budgets
• Understand and participate in bidding programming work
• Demonstrated leadership, motivation and problem solving capability
• Good understanding of clinical trials
• Effective attention to detail
• Capable of effectively organizing and managing multiple staff and assignments
• Effective written and verbal communications skills
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others and
adjust to changing priorities
• Proficiency in at least one programming language and strong technical programming skills
Management Role:
No management responsibility
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
