Clinical Biostatistician - Biopharmaceutical - Colorado

This position is open as of 5/10/2008. Are you a fit? Click Here to Apply Now! Job Details Clinical Biostatistician - Biopharmaceutical - Colorado renderImage('http://www.cybercoders.com/images/search.png', 84, 39); 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   5/10/2008 Job Description Skills Required Clinical Biostatistician, Biopharmaceutical, SAS programming, Regulatory, Clinical Trial Design Job Description Clinical Biostatistician - Biopharmaceutical - ColoradoWe 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 meetingsRequirements: * 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! Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: Email your resume in Word to: David.Wright@CyberScientific.com **Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-CO-Biostat1 -- in the email subject line for your application to be considered.*** David Wright - Senior Recruiter - CyberScientific   logET();PauseFooter(false);