Contract Statistician

Fladger Associates; Silver Spring (MD); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company is seeking a Contract Statistician for remote or on-site work in Gaithersburg or Frederick, MD. This role involves providing statistical support across various technical areas in biopharmaceutical processes, applying advanced methodologies, and leading projects. Ideal candidates have substantial industry experience and proficiency in statistical software, contributing directly to process optimization and regulatory compliance.

Qualifications

• Minimum of 10 years with BS, 5 years with MS, 3 years with Ph.D.
• Strong proficiency in SAS and JMP required; R, Matlab a plus.
• Experience in Biopharmaceutical, Pharmaceutical, or Medical Device industries.

Responsibilities

• Provide statistical support for GTO and global company sites.
• Implement advanced data mining and monitoring tools.
• Collaborate with statisticians for improvement and standardization.

Skills

Statistical support

Data mining

Analytical thinking

SAS

JMP

R

Matlab

Education

BS in relevant field (minimum 10 years)

MS (minimum 5 years)

Ph.D. (minimum 3 years)

Job description

Remote; Gaithersburg or Frederick, MD Contract Duration : 12-36 months Rate : Negotiable Salary : NA $1.00 Responsibilities :

Excellent employment opportunity for a Contract Statistician in the Gaithersburg or Frederick, MD area. The Contract Statistician in company Global Technical Operations (GTO) will work under the direction of the GTO statistician.

Responsible for providing statistical support across a broad range of technical areas, including analytical, process development, drug substance and drug product manufacturing monitoring, process / product / assay trending, and promoting applications of statistics in analytical and process development, validation and optimization.

Also responsible for providing direction and statistical oversight for the internal and external projects that GTO leads / supports. Provide statistical support for GTO and global company sites

Maintain models to summarize current level of process and product understanding Implement advanced data mining and monitoring tools to track process performance and product quality for commercial production across sites Apply statistical methods to facilitate better decision making and improve business operation Collaborate with statisticians in other departments for improvement and standardization of statistical methods Collaborate with colleagues from other divisions or departments to achieve corporate goals Lead or participate in establishing global statistical guidelines Represent GTO on cross-project initiatives such as specification strategy, QbD and PAT Remote; Gaithersburg or Frederick sites

Experience :

Minimum of 10 years with BS, 5 years with MS, and 3 years with Ph.D. Minimum of 3 years of experience in Biopharmaceutical, Pharmaceutical, or Medical Device industries. Strong proficiency in SAS and JMP statistical software required; R, Matlab, or other software a plus Expertise in applied statistical methodologies including linear and non-linear mixed models, statistical intervals, experimental design, probability methods, and simulation Data mining and analytics experience a plus

Demonstrated application of statistical techniques to solve problems in analytical, process, and CMC areas

Development, validation and transfer of analytical methods Derivation of acceptance criteria

Characterization, optimization, technology transfer, and comparability of biological product manufacturing processes Statistical process control and process capability analysis

Data mining large sets of process and manufacturing history

Life cycle management of specifications for commercial products Stability data analysis Contribute to the development of novel statistical methods to resolve problems in manufacturing operations and analytical testing Apply advanced statistical principles, theories, and concepts to make life-cycle changes to manufacturing processes and analytical specifications Comprehensive knowledge of regulatory guidelines Experience in interactions with regulatory agencies and submissions Familiar with pharmaceutical or biotechnological manufacturing processes and regulations Demonstrated competency in managing multiple projects and processes Excellent oral and written communication skills Work under limited consultative direction toward predetermined long-range goals and objectives.

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Statistician • Silver Spring, MD, United States