Summary of The Position:
The Statistical Programmer will perform statistical and database programming (typically in SAS) related to clinical projects undertaken by FHI Clinical, according to the relevant trial protocol and other trial-related documentation, ICH GCP (and local adaptations thereof), local legal requirements, relevant FDA, EMA, and other international guidelines, as well as applicable procedural documents.
The Statistical Programmer will serve as the lead statistical programmer and program analysis data sets, tables, figures, and listings (TFLs) for complex or high-profile studies. With minimal guidance, generate/design TFL shells and analyze data set specifications. Conduct ad hoc analysis as requested. QC or review statistical reports for internal or cross-form inconsistencies. Maintain program documentation. Create SAS macros or other tools to enhance the efficient delivery of statistical services, providing associated used documentation and staff training as needed.
The Statistical Programmer should communicate with team members about statistical programming related to trial timelines, data quality, and results interpretation.
Essential Functions:
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Write statistical analysis programs using SAS or other statistical software or languages for a high volume of studies and/or more complex high-profile studies.
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With minimal direction, design and generate TFL shells and analysis data set specifications using protocol, statistical analysis plan, or other study materials.
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Critically review the analysis plan or other study materials as needed.
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Work with the biostatistician or designee as needed to coordinate the provision of summary reports to study teams.
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Service as a statistical programming resource to other data analysts in and outside of the department.
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Design, create and document SAS macros or other tools.
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Write associated user documentation and train staff as needed.
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Propose new macros or other tools to enhance efficiency and accuracy.
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Review statistical packages and accompanying documentation for internal and cross-form inconsistencies and accuracy of description of data handling methods.
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With appropriate training, design and write randomization programs and prepare associated material for randomization statisticians.
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Provide biometrics programming support to clients and to other internal departments, as required and requested by the Global Head or designee.
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Assist the Global Head or designee with delegated tasks and responsibilities, including but not limited to support in preparing and reviewing Procedural Documents and filing and maintaining clinical trial documents in the designated sections of the Trial Master Files.
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Any other duties and responsibilities that may be assigned occasionally.
Knowledge, Skills, and Abilities:
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Demonstrated expertise in SAS programming and SAS macro language, particularly in more complex data settings.
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Able to communicate in English effectively and accurately, both orally and in writing.
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Uncompromising attention to detail and excellent logical/analytical skills.
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Organization and planning ability.
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Sound problem-solving and decision-making skills.
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Ability to, with minimal supervision, work well independently and within a team setting and manage high-volume work flow.
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Solid understanding of statistical concepts and commonly used methods.
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Solid understanding of ethical principles and programming standards/best practices as they apply to research analysis.
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Computer skills and the ability to acquire proficiency with appropriate software packages.
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Good interpersonal skills.
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Proficient knowledge of international and local regulations and guidelines applicable to clinical research.
Position Requirements
Education: Bachelors' degree or international equivalent, in a quantitative field involving statistical analysis (Statistics, biostatistics, bioinformatics, etc.)
Preferred Job-related Experience: A minimum of two years' experience as a Statistical Programmer on research studies directly relevant to expected project assignments, showing progression to greater independence, responsibility, and/or programming sophistication (i.e. working on more complex or high-profile studies).
Additional Eligibility Qualifications: Proficiency in SAS, R optional
Preferences: None.
Special Position Requirements: None.
Physical Expectations:
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Typical office environment.
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Ability to spend long hours looking at computer screens and doing repetitive work on a keyboard.
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Ability to sit and stand for extended periods of time.
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Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.
Travel Requirements:
This position expects less than 10 % travel time.
This job description is not intended to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. and its subsidiary and affiliate companies provide equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
