Job Description

Position Summary:   As a Principal Biostatistician you will be a key member of the Clinical Development Operations, Biostatistics Team. You will s erve as primary statistical representative for biometrics standalone projects or otherwise complex studies. Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology. Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. Manage and/or mentor junior level biostatistics staff.

Position Accountabilities/Responsibilities:

• Apply knowledge of basic and complex statistical design, analysis, and programming techniques. 
• Efficiently and effectively coordinate statistical activities for multiple projects simultaneously. 
• Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies. 
• Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. 
• Maintain a professional working relationship with sponsors, collaborating associates, and vendors. 
• Represent department and company in a multi-disciplinary setting, including project team meetings and client meetings/presentations. 
• Effective oral and written communication of statistical concepts and results. 
• Develop and review of statistical analysis plans based on study specific documents and sound statistical methodology. 
• Assist in developing, maintaining, and producing statistical programs and specifications used in creating analysis datasets, tables, listings, and figures. 
• Ensure the quality and integrity of data analysis and reporting. 
• Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate. 
• Actively monitor project budgets and help staff identify resource or scope of work changes. 
• Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management. 
• Attend related continuing education programs, professional meetings, and other career development activities sponsored. 
• Perform all other related duties as assigned. 
• Interact across operational areas as required. 
• Interact with sponsor representatives as required. 

Supervisory Requirements/Responsibilities: Position will have management responsibilities.  Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, performance appraisals, goal setting, & salary.

Position Qualifications and Requirements: 

Education:

• Master’s degree, equivalent, or higher in biostatistics or a related field. 
• (A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.) 

Experience : 

• A minimum of 7+ years of relevant work experience. 
• Capable of conducting exploratory statistical analyses using statistical software packages. 
• Knowledge of CDISC submission and integrated safety and efficacy summary. 
• Previous experience in a pharmaceutical research or CRO setting required/preferred. 

Required Certifications :  N/A

Required Skills :  

• Proficient with Microsoft Office Suite. 
• Knowledge of clinical trial study design. 
• Able to work independently on multiple, concurrent projects.  
• Can attend study team meetings as needed. 
• Excellent written and oral communication skills. 
• Excellent presentation skills. 
• Strong organizational, problem-solving, and analytical skills. 
• Ability to manage priorities and workflow. 
• Versatility, flexibility, and a willingness to work within constantly changing priorities. 
• Proven ability to handle multiple projects and meet deadlines. 
• Strong interpersonal skills. 
• Ability to deal effectively with a diversity of individuals at all organizational levels. 
• Commitment to excellence and high standards. 
• Creative, flexible, and innovative team player. 
• Good judgement with the ability to make timely and sound decisions. 
• Ability to travel frequently for meetings or training activities may be required. 

Working Conditions:  ​Sedentary work that primarily involves sitting/standing.

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