Clinical Biostatistician - Biopharmaceutical - Colorado
CyberScientific (Denver, Colorado)

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Clinical Biostatistician jobs in Denver, CO Clinical Biostatistician - Biopharmaceutical - Colorado

This position is open as of 5/12/2008.

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Click Here to Apply Now! Job Details Clinical Biostatistician - Biopharmaceutical - Colorado Specifications Location     Denver, CO; Boulder, CO Salary     $90,000 - $110,000 Education     Bachelor of Science Category     Pharmaceutical Experience Required     At least 2 Years Short Description     Clinical Biostatistician - Biopharmaceutical - Colorado Required Skills     Clinical Biostatistician, Biopharmaceutical, SAS programming, Regulatory, Clinical Trial Design Recruiter     David Wright Date Updated     5/12/2008 Job Description Skills Required

Clinical Biostatistician, Biopharmaceutical, SAS programming, Regulatory, Clinical Trial Design

Job Description

Clinical Biostatistician - Biopharmaceutical - Colorado

We are focused on the discovery, development and commercialization of targeted small molecule drugs to treat debilitating and life-threatening diseases. Our drug development pipeline is focused on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important targets. We also have leading pharmaceutical and biotechnology companies collaborate with us to discover and develop drug candidates across a broad range of therapeutic areas.

Description:

* Project-manage all study team activities within Biostatistics according to agreed resource and timeline plans
* Create statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis)
* Review and approve randomization specifications
* Create statistical analysis plans
* Create templates for tables, listings and graphs
* Review and approve SDF dataset specifications
* Review and approve key study-related documents produced by other functions (e.g. CRFs, Data Management Plans etc)
* Write, test, validate and execute software programs to produce SDF datasets and tables, listings and graphs (statistical analysis outputs) for inclusion within CSRs, ISS / ISE, publications and other communications
* Participate in the finalization of protocol deviations and analysis sets
* Approve database freeze
* Unblind, load and check accuracy of treatment assignment data
* Create flash reports
* Create statistical text for CSRs, clinical publications and other communications
* Plan and execute statistical review and QC of CSRs, clinical publications and other communications;
* Assist in planning and contribute to compilation of ISS/ISE
* Oversee the work of outsourcing partners and vendors at study level
* Create Requests for Proposals (RFPs) from outsourcing vendors for statistical services
* Contribute to decisions on selection of outsourcing partners
* Participate in the development and review of SOPs and other controlled documents; Participate in study and systems audits by CQA and external bodies, and respond to audit questions and findings.
* Participate in Strategy meetings
* Contribute to strategy via writing statistical elements of GDP
* Lead and project-manage all GDT statistical activities according to agreed resource and timeline plans
* Develop and maintain standardized statistical approaches and methodology.
* Participate in study team meetings

Requirements:
* MS or PhD with a Statistics/Biostatistics major or emphasis in related field.
* 8+ years (MS) or 4+ years (PhD) of experience in designing and supporting clinical trials is required.
* Experience with SAS
* Experience with clinical data management systems
* Experience in supporting regulatory submissions and post-marketing activities.
* Oncology or Rheumatology/Inflammatory disease experience preferred.
* Good oral and written communication skills.
* Demonstrated ability to work effectively in a team environment.
* Understanding of state-of-the-art technologies in statistical applications; able to evaluate and leverage them to improve business processes.
* Understanding of and enthusiasm for enhanced clinical trials designs (e.g., adaptive designs).

Must be authorized to work in the United States on a full-time basis for any employer.

Location: Denver, Colorado; Boulder, Colorado Want to interview today? Click Here to Do a Quick 2-Minute Online Interview!

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David.Wright@CyberScientific.com
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David Wright - Senior Recruiter - CyberScientific