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Remote Sr. Biostatistician

NES Global Talent

This is a Full-time position in Atlanta, GA posted March 18, 2021.

nn Remote Sr.

Biostatistician nn nn nn nn Responsibilities nn Assist in strategic planning and develop optimal clinical development plans with cross-functional drug development teams.

Oversee multiple studies for one compound to ensure the consistency of statistical work standards as the project statistical leader Responsible for writing statistical methodology section of the protocol, including sample size calculation.

Responsible for writing statistical analysis plans (including mockup TLFs) for individual studies and ISS or ISE.

Plan regulatory filings and ensure a timely submission with efficiency and accuracy in regulatory filing activities.

Direct the activities of internal and external statistical programmers to ensure the intended analyses are performed, and analysis data sets and their specifications are in place following CDISC standards.

Review and comment on eCRFs, annotated eCRFs, edit checks documents and other clinical data management related documents.

Lead the cross functional team to develop IWRS and oversee system testing Participate in operations meetings and address issues related to biostatistics.

Support and participate in the preparation of study reports, regulatory submissions and annual IND safety update reports.

Perform ad hoc analyses and validation of analysis results.

Develop and contribute to Biometrics SOPs and standard working documents meeting regulatory requirements throughout biometrics processes, including IWRS/EDC, STDM, statistical programming for TLFs and data reporting.

Write simulation code and simulation report in compliance with regulatory agency requirements for adaptive design trials.

nn Job Requirements nn statistics/biostatistics with minimum 8-10 years of biopharmaceutical statistics experience; Master’s degree in statistics or biostatistics with a minimum of 10-12 years of experience with specific experience in late stage drug development, including phase IIb, phase III and submissions in the pharmaceutical industry.

Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.

Experience in Biostatistics, SAS programming and clinical data management in a regulated clinical research environment.

Knowledge of adaptive design, missing data handling, multiple comparisons and simulation techniques.

Experience in organizing regulatory submissions, such as BLA, NDA, sNDA and MAA submissions.

nnLocation:nn nnRemote, Anywhere in the USnn n n Job Requirements: n Develop statistical analysis plan (SAP) Building statistical models and performing statistical testing Lead and perform the statistical planning and statistical analysis of clinical studies Write statistical analysis plans and statistical sections of protocols based on statistical principles and methodology Perform senior review of statistical reports, statistical sections of clinical study reports, and integrated statistical and clinical reports Maintain the statistical integrity of clinical trials Prepare data validation and accurate statistical analysis data sets for analysis Applying statistical methodology to complex data Perform data review and statistical analyzes Specified in statistical analysis plan and ad-hoc analysis Conduct statistical analysis and reporting of analyzes Write reports describing results of statistical analysis Prepare statistical sections of protocols Report and statistical analysis tables/figures/listings Collaborate writing statistical sections for integrated reports or/and statistical reports Provide statistical input for publications on clinical trials Prepare statistical analysis plans (SAPs) and statistical reports Provide statistical consulting and training Ensure statistical integrity and consistency Deliver presentations on statistical research

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