Objective

Reporting to the Chief Medical Officer, the Senior Director, Biostatistician, is responsible for directing the design, development, modification, and evaluation of a technical infrastructure to expedite the operation and evaluation of clinical trials.  S/he will monitor statistical analysis activities, managing the evaluation of clinical data statistics, and develop tracking systems to determine the efficiency of clinical trials.  Also key to this role will be selecting, developing, and evaluating personnel to ensure the efficient operation of this important function for the company. 

Essential Functions
 

• Study Design – In collaboration with other team members, develop appropriate methodologies for addressing study hypotheses.  For some studies, this may include participation in the research design phase of projects.  For others, it may be development of methodologies for later stage projects currently underway.
• Data Management – Work with other clinical and programming personnel to design, develop, and maintain appropriate databases.  Develop a program to ensure data integrity (logic and range checks, double-data entry procedures).  Develop efficient data archival systems for use with multi-center collaborations.  Maintain detailed written documentation of all data programming and data archival systems
• Data Analysis – Consult with Perspective Therapeutics’ clinical leaders to determine appropriate statistical methods.  Perform statistical programming and analysis for multiple research studies, with guidance from other team members using various statistical models.  Create analysis datasets, summarize data, and create reports using SAS.  Develop statistical analysis plan (SAP) based on study protocol and produce TLF shell according to SAP.  Develop statistical sections of clinical study documents, including but not limited to study synopsis/protocol and clinical study report.  Assess the appropriateness of final statistical models.  Perform quality control and validation of peer statistician and statistical programmer’s work.  Document methods and results via written memoranda and reports.  Provide statistical guidance for on-going and planned clinical studies.
• General Support – Provide validation and review services for internal and external projects. Write up and communicate findings as necessary.  Maintain archives of study data and relevant programming documentation.  Participate in the development of internal guidelines and Standard Operating Procedures.  Conduct statistical simulations for evaluating and developing novel clinical trial designs.  Prepare project updates for weekly/monthly status meetings.  Maintain up to date knowledge of statistical methodology and relevant regulatory guidance.
• Prepare Research Reports – Assist in the writing and preparation of research reports, including internal documentation, academic publications, and research presentations at national meetings.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education / Experience

• Master’s degree in Biostatistics, Statistics, or a related field with strong quantitative training.  PhD preferred.
• A minimum of 10 years of experience in the pharmaceutical/biotech industry or academia, preferably the majority in oncology drug development.
• Must have expertise in state-of-the-art data manipulation and statistical analyses.
• Must have a strong background in applied statistics is necessary to perform the types of complex analyses imaging data generally demands.
• Proficient in at least three of R, SAS, SPSS, M-Plus or STATA.
• Skills in descriptive analysis, modeling of data, study design and graphic interfaces.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge / Skill / Ability
 

• Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
• Outstanding ability to communicate technical information to both technical and non-technical audiences.
• Demonstrated ability to work independently, manage projects and lead change across the organization.
• Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
• Ability to manage and prioritize multiple projects to ensure on-time delivery with meticulous quality.
• Ability to become well-versed with relevant medical and imaging concepts and terminology.
• Ability to facilitate meetings and discussions in person and virtually.
• Ability to travel up to 10%.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 

• May be required to sit or stand for long periods of 8 hours a day while performing duties. 
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

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