Senior / Principal Statistician

Job Description

This position will oversee all statistical aspects of assigned projects & be responsible for introducing and ing new methodology where appropriate. Statisticians serve as consultants to our clients and are responsible for the conduct of the statistical analyses of our client s research & development projects. Ultimately, our Statisticians ensure that activities and processes performed are conducted according to company and client s SOPs.

Responsibilities

• Serve as the primary contact to clinical operations, data management, programming, medical writing, regulatory & other departments for all matters pertaining to statistics.
• Consult on clinical trial design, sample size estimates and statistical methodology
• Provide statistical input regarding clinical trial design, statistical analysis, reporting, and interpretation, etc.
• Interact with other departments, such as clinical operations and project management, to ensure a high level of client satisfaction through successful execution of projects.
• Validate Statistical output to ensure that it accurately portrays the outcome of the clinical trial, being able to accurately interpret & clearly communicate statistical results & concepts.
• Relay the Top Line results to the appropriate parties.
• Review the CSR for accuracy with respect to the interpretation of the statistical analyses.
• Develop the Statistical Analysis Plan and mock ups of tables, listing, and figures.
• Work with study team during (e)CRF development to ensure adequacy of data collection with respect to statistical endpoints derivability.
• Prepare ADaM mapping documentation.
• Provide SAS programming support for data analysis and statistical reports as needed.
• Develop and execute QC programs datasets, tables and figures.
• Act as a representative of the biostatistics department on project teams. Attend project team meetings as necessary.
• Provide input to SOPs and standardization efforts (e.g. statistical methodology standards, standard data presentations, standard CRFs, etc.)
• Analyze clinical trial data producing accurate results representing the outcome of the trial.
• Other duties as assigned

Additional Levels of Responsibility

• Responsible for statistical deliverables for assigned projects.
• Responsible for statistical input to clinical study reports and other reports.
• Serve as the statistical representative on multi - disciplinary teams preparing protocol; responsible for statistical input.
• Mentor less experienced statistician within project activities.
• Participate in interdepartmental processes.
• Provide statistical input into other disciplines and participate in interdepartmental processes.
• Contact with clients and regulatory agencies across multiple disciplines.
• Contribute to the review and amendment of departmental processes and supporting documentation.
• Contribute to proposal activities and client presentations as needed.
• Represent Biostatistics during project driven client audits as needed.

Working Relationships:

• Reports directly to Director of Biostatistics
• Liaise with all facets of the organization

Qualifications

• MS/PhD in statistics or related fields
• PhD in statistics or related field with 6 years of experience or an MS in statistics or related field with 8 years of experience in the development of pharmaceuticals, biologics, and/or medical devices.
• Prior experience as a lead statistician.
• Knowledgeable of all phases of clinical studies.
• Demonstrated problem solving skills and strategic planning ability
• Practical and technical knowledge of statistical analyses in support of Phase 1 - 4 clinical trials or medical device studies.
• Demonstrated ability to effectively communicate to external and internal clients.
• Good communication / interpersonal skills for effective client consultations
• Ability to manage concurrent projects.

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Keyskills :
dataanalysis studyreports medicaldevices medicalwriting datamanagement datacollection problemsolving clinicaltrials sasprogramming projectmanagement strategicplanning clinicaloperations clientsatisfaction regulatoryagencies statisticalanalys