Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Acts as the lead programmer or project lead on multiple projects, overseeing statistical and bionformatics programming aspects of clinical trials from design through analysis and reporting. Able to act in the project oversight role on select projects. Oversees the organizing of teams to implement study strategies to ensure process and programming efficiencies, and oversees the creation and maintenance of standard programs for statistical report generation, and program validation. Represents the department within the company and with interactions with client companies and regulatory agencies on study matters, bid defenses or submission of clinical data to regulatory authorities, directly contributing to and/or leading proposals and bids. Provides training, guidance, and project leadership to junior team members.
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Essential Functions:
1. Serves as a lead programmer or project lead on studies or drug programs of all complexities and size scales, including NDA submissions. Works directly with project team leaders and client representatives to conduct team meetings, to oversee the development and maintenance of project timelines, ensuring
forecasting of resources is maintained, and is accountable for study budgets and being familiar with any relevant contractual obligations or limits with our clients.
2. Leads contract modification discussions with client where necessary.
3. Suggests, plans and provides developments to tools and techniques for
improving process efficiencies. Collaborating with senior management, actively
organizes and independently leads process or tool improvement efforts.
4. May serve as company project manager on projects limited to only biometrics services.
5. May serve in a project oversight role on selected projects, including NDAs.
6. May serve in a contributor or reviewer role of key submission materials for
regulatory authorities.
7. Provides general infrastructure support to the Department, including
representing the company at industry conferences, presenting/teaching at
department meetings, assisting in establishing training materials, contributing to other general department documents or policies, and contributing to process
improvement and department initiatives.
8. Increases knowledge base and professional skills for self and junior team
members if applicable, in areas including programming technology and
techniques, clinical trials, and developments in the pharmaceutical industry.
9. Provides feedback to managers on employee performance for employee
development, performance reviews and training.
10. Leads the promotion and visibility of the company in the industry by making
presentations at industry conferences and/or chairing industry conference
sections.
Education and Experience:
MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 7 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 9 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
Knowledge, Skills and Abilities:
• Excellent SAS® programming skills
• Mastery of database structures and working with complex data structures
• Demonstrated excellent attention to detail
• Exceptional problem solving and innovative skills
• Exceptional written and verbal communication skills to facilitate communications with clients, project
teams, departments and staff, including proficiency in the English language
• Capable of independently organizing, adapting and adjusting to changing priorities across multiple
assignments
• Capable of working and leading in a multidisciplinary team setting
• Demonstrated positive attitude and the ability to work well with others
• Capable of coaching and mentoring others, as shown by leadership of projects
• Excellent understanding clinical trials, ICH Statistical and reporting guidelines and GCP
• Exceptional knowledge of statistical principles applied to the design and analysis of clinical trials
• Excellent understanding of the requirements involved in the submission of clinical data to regulatory
authorities
• Exceptional project management skills, such as project budget creation, including modifying for
project updates, and managing project budgets and risks
• Capable of interpreting and contributing to company policies
• Delivery and quality drive