Acts as the lead programmer, project lead, or project oversight lead on multiple projects, overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting.
Organizes teams and implements study strategies to ensure process and programming efficiencies, and the creation and maintenance of programs for statistical report generation, and program validation.
Represents the department within the company and with interactions with client companies and regulatory agencies.
Provides training, guidance, and project leadership to junior team members.
Essential Functions: Serves as a lead programmer or project lead on studies or drug programs of all complexities and size scales.
Works directly with project team leaders andclient representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and ensure adherence to study budgets and any relevant contractual obligations or limits with clients.
Suggests, plans and provides developments to tools and techniques for improving process efficiencies. Actively contributes to process or tool improvement efforts including leadership of solution teams.
Represents the department to clients on study matters, bid defenses or submission or review of clinical data to regulatory authorities, directly contributing to proposals and bids.
May serve as company project manager on projects limited to only biometrics services.
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.
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. Provides feedback to managers on employee performance for employee development, performance reviews and training. Works to increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences. Contributes to the department recruitment/candidate interview process
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: Strong SAS® programming skills Great understanding of database structures and working with complex data structures Demonstrated great attention to detail
Excellent problem solving and innovative skills
Excellent 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 Good understanding clinical trials, ICH Statistical and reporting guidelines and GCP Excellent knowledge of statistical principles applied to the design and analysis of clinical trials
Good understanding of the requirements involved in the submission of clinical data to regulatory authorities
Excellent 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 driven