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    • stamford, connecticut (remote)
    • contract
    • $130 - $133.25 per hour
    job summary: A clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer is actively seeking (1) highly skilled Senior Biostatistician for a contract role beginning June and going through the end of the year. The Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas. This role will lead protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, CRFs and data edits and serve as lead biostatistician for assigned project(s). You will perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate.   location: Stamford, Connecticut job type: Contract salary: $130.00 - 133.25 per hour work hours: 9 to 5 education: Masters   responsibilities: Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategyDefine statistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project (e.g. statistical consideration of synopses or protocols, statistical analysis plans, etc.); ensures the quality of their deliverables.Assist responses to addressing statistical issues are part of regulatory, legal or other challenges to the company's products or processes; may represent Biostatistics in key meetings as assignedServe as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industryParticipate in approved process improvement initiatives;Conducts modelling and simulations as neededPromote the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Biometrics department through her/his expertise and customer orientation.Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials  qualifications: Master's degree in statistics or biostatistics required. PhD preferred. Sr. Statistician level - approximately 7 years experience (give or take)Experience in smaller team settings is desirable - this position will be a lead positionOncology experience is preferred, but not requiredExperience in statistical or biostatical analysis supporting clinical trial operations for the pharma/biotech industryPast regulatory interactions preferredBroad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.Ability to develop innovative/creative statistical/technical solutions to complex problems.Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.Proficient with SAS, S-Plus/R, Sample size calculation software (e.g., East, PASS, NQuery)Knowledge of CDISC data standardsAbility to write statistical code and documentation  skills: Data Analysis, CDISC, CRFs, Data Management Plan, Data Validation Plan, R Language, S Language, SAS Macro, SAS/GRAPH, SAS/PH, SAS/STAT, Biostatistical Analysis Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
    job summary: A clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer is actively seeking (1) highly skilled Senior Biostatistician for a contract role beginning June and going through the end of the year. The Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas. This role will lead protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, CRFs and data edits and serve as lead biostatistician for assigned project(s). You will perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate.   location: Stamford, Connecticut job type: Contract salary: $130.00 - 133.25 per hour work hours: 9 to 5 education: Masters   responsibilities: Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategyDefine statistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project (e.g. statistical consideration of synopses or protocols, statistical analysis plans, etc.); ensures the quality of their deliverables.Assist responses to addressing statistical issues are part of regulatory, legal or other challenges to the company's products or processes; may represent Biostatistics in key meetings as assignedServe as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industryParticipate in approved process improvement initiatives;Conducts modelling and simulations as neededPromote the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Biometrics department through her/his expertise and customer orientation.Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials  qualifications: Master's degree in statistics or biostatistics required. PhD preferred. Sr. Statistician level - approximately 7 years experience (give or take)Experience in smaller team settings is desirable - this position will be a lead positionOncology experience is preferred, but not requiredExperience in statistical or biostatical analysis supporting clinical trial operations for the pharma/biotech industryPast regulatory interactions preferredBroad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.Ability to develop innovative/creative statistical/technical solutions to complex problems.Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.Proficient with SAS, S-Plus/R, Sample size calculation software (e.g., East, PASS, NQuery)Knowledge of CDISC data standardsAbility to write statistical code and documentation  skills: Data Analysis, CDISC, CRFs, Data Management Plan, Data Validation Plan, R Language, S Language, SAS Macro, SAS/GRAPH, SAS/PH, SAS/STAT, Biostatistical Analysis Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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