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Miles
Km80.5

Manager, Biostatistics

Clinical Dynamix, Inc.

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Location: Relocation provided, MO Posted Date: 4/8/2013 Position Type: Full time Job Code: 12345 Required Education: Masters Degree Areas of Expertise Desired: Biostatistics
Clinical Research

Description

Manager, Biostatistics is responsible for leading the planning, statistical analysis and reporting for assigned clinical and/or non-clinical projects using both internal and external resources.  This position has no direct reports.

ESSENTIAL FUNCTIONS:
•   Evaluates statistical design of studies including sizing;
•   Writes statistical analysis plans and statistical sections of protocols.
•   Reviews protocols, case report forms, data management plans, sample size estimates, randomization schedules, clinical study reports and sections of regulatory submissions; and performs statistical analysis in support of product regulatory submissions.
•   Assures acceptability and scientific integrity of data collection and analysis through appropriate application of statistical principles and methodology, and is able to argue logically in support of study results and conclusions.
•   Develops statistical analysis strategies and selects appropriate methodologies for research studies involving pharmaceuticals, contrast imaging agents, and medical devices.
•   Applies statistical theory and analysis methods to data to ensure a sound scientific basis for product performance claims.
•   Functions at discretionary level of autonomy and without appreciable direction as deemed appropriate by Director of Biostatistics.
•   Manages departmental interactions with external resources such as Contract Research Organizations and statistical consultants.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:
This position reports to the Director, Biostatistics and has no direct reports.  Will interact with different departments throughout the Pharmaceuticals organization (i.e. Clinical Operations, other R&D departments, etc.)

Requirements

MINIMUM REQUIREMENTS:

Education:   Master’s degree in Biostatistics or closely related field required. PhD preferred.

Experience:   A minimum of 8 years experience required in the design, analysis, and reporting of clinical trials for regulatory submissions. Participation as statistical lead in meetings with regulatory authorities preferred.

Preferred Skills/Qualifications:   Presentation skills and comfort with presentations to non-statistical audiences. High degree of knowledge about and proficiency in SAS programming.

Skills/Competencies:   Expertise in biostatistical methodologies common to clinical trials. Knowledge of relevant regulatory guidance (ICH E-series, EMEA Points to Consider). Ability to accomplish objectives in a matrix organization including external contributors.
RELOCATION ASSISTANCE PROVIDED
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