FHI 360

Clinical Biostatistician

FHI 360

Job Description

  Serves as a functional lead Biostatistician on clinical trial studies of intermediate complexity or as strong support to functional lead on highly complex and/or high-profile studies. As lead, responsible for the provision of statistical services such as: Design, Analysis, and reporting of clinical and other studies. Writes statistical analysis plans (SAPs), performs statistical analyses, oversees the work of more junior statisticians conducting tasks associated with provision of statistical services, and contributes to and reviews study reports. As lead, interacts with other study team members and clients on study set up (including randomization) and conduct, and statistical Project Management (including timelines and financial oversight). Serve as Independent Statistician to Data and Safety Monitoring Boards (DSMBs). Contribute to the development and maintenance of departmental systems, including management tools. May referee protocols and manuscripts written by investigators in other departments or divisions.

Accountabilities:

  • Using specification documents, write statistical analysis programs using SAS or other statistical software to generate or validate analysis data sets and tables, figures, listings (TFL) for statistical reports.

  • As validator, investigates source of discrepancies in data and/or program code; reviews completed TFL for accuracy, including textual material (titles, headings, footnotes, etc.).

  • Write and maintain accurate program documentation and generate TFL shells from existing macro or other sources.

  • Develop analysis data set and TFL specifications.

  • Write analysis programs in SAS or other software.

  • Design and generate TFL shells and analysis data set specifications, using protocol, statistical analysis plan, or other study materials.

  • Carry out intermediate to advanced statistical analysis, and assess validity of analysis assumptions.

  • Help draft statistical sections of study reports.

  • Review study reports and manuscripts for accuracy of reporting and inference.

  • Write analysis programs in SAS or other software for complex and/or critical analyses.

  • Responsible for accurate and timely delivery of statistical services: determines resource needs and schedules; coordinates with manager regarding project status, budget, and changes in scope.

  • Provide statistical input and expertise to study team on all aspects of study conduct that impacts analysis or other statistical tasks (e.g. randomization)

  • Coordinate work of more junior staff.

  • Serve as statistical consultant to researchers on study design, sample size and analysis of clinical trials and other studies of simple to moderate complexity.

Applied Knowledge & Skills:

  • Able to function independently as lead statistician

  • Solid understanding of scientific and ethical principles and industry best practices in research analysis

  • Understanding of special requirements of unblinded interim analysis.

  • Increased breadth or depth of statistical knowledge relative to Level II, such as: working knowledge of more complex methods, wider range of therapeutic areas; or analysis methods for a broader range of study designs.

  • Ability to communicate and interact effectively with non-statistical colleagues on project teams.

  • A unique skill set (e.g. programming language)  or area of statistical application (e.g. pharmacokinetics) can substitute for consulting and writing responsibilities

Problem Solving & Impact:

  • Anticipates problems and proactively works to avoid them

  • Uses logic and understanding of scientific reporting to make appropriate decisions regarding Data Handling

  • Exercises judgment in selecting methods and techniques for obtaining solutions.

  • Uses good judgment in projecting and managing resources and timelines

Supervision Given/Received:

  • Reports to a more senior biostatistician.

  • With minimal supervision, manages a high-volume work flow.

  • Uses judgment to execute duties and responsibilities.

  • May oversee the work of junior staff on specific tasks but does not have general supervisory responsibilities.

Education:

  • Masters’ degree (or international equivalent) in statistics, Biostatistics, bioinformatics or similar curriculum.

  • PhD preferred

Experience:

  • Typically requires 5 - 8 years’ relevant work experience in statistical analysis of research studies.

  • Demonstrated proficiency in functions required of a lead statistician, including interpersonal and communication skills necessary for effective interactions with study teams

  • Demonstrated skills in multiple statistical areas and/or therapeutic indications.

  • Excellent Interpersonal Communication skills, verbal and written English.

  • Experience in statistical aspects of study design.

  • Experience providing statistical consultation to researchers.

Typical Physical Demands:

  • Typical office environment.

  • Ability to sit and stand for extended periods of time.

  • Ability to lift 5-50 lbs.

Technology to be Used:

  • Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.

Travel Requirements:

  • Less than 10%

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time. FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable Law. FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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