Statistician

Responsibilities

• 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 department's Working Practice Documents and contributes changes as needed.
• Follows departmental procedures for statistical analyses and programming work.
• Works 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.
• Maintains project budget as it relates to project work scope and communicates 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.

Requirements

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years').
• A Master's degree in statistics, biostatistics, mathematics or related field.
• 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.
• Strong SAS? programming skills. (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures.
• Capable of directing and promoting teamwork in a multi-disciplinary 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.