ACCOUNTABILITIES: 

1.       Leadership and Project Management:

• Participate and/or lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations.
• Assist the Lead Biostatistician and/or Lead Programmer on assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client’s trust and repeat business.
• Assist the Lead Biostatistician and/or Lead Programmer for a developmental program with more than one or two trials, coordinating with other Biostatisticians and Programmers as well as project/program overall management personnel to achieve program objectives.

2.       Statistical Planning and Methodologies:

·         Under supervision to provide statistical expertise for design, analysis and reporting of clinical trials and research projects.

·         Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.

·         Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments.

·         Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs.

·         Provide input to unblinded data management plan when required.

·      Participate in research and development of statistical methodologies and processes.

3.       Statistical Programming:

·         Develop and/or review SDTM and ADaM dataset specifications.

·         Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs.

·         Participate in statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues.

·         Develop SDTM Study Data Reviewer’s Guide, discuss and incorporate Data Standards Reviewer’s review comments to ensure quality of the document.

·         Develop ADaM Analysis Data Reviewer’s Guide, discuss and incorporate Data Standards Reviewer’s review comments to ensure quality of the document.

4.       Statistical Analysis and Reporting, Publication Support:

·         Perform statistical modeling and analyses, implement new statistical analysis methods and strategies.

·                     Perform statistical analysis as per SAP, and address peer/QC review comments and findings.

·         Perform statistical validation of study results, address additional QC validation comments and findings on the results.

·         Plan and conduct or contribute to the trial results reporting/dissemination meetings.

·         Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results.

·         Write statistical report or statistical sections of the CSR, or perform peer review of the contents.

·         Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters.

5.       Supporting Clinical Data Collection and Cleaning:

·         Provide statistical input to Case Report Forms (CRF) design and database/variable structure.

·         Provide statistical input to non-CRF data collection and acquisition methods and approaches.

·         Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.

·         Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.

·         Perform ongoing assessment and communication of data quality issues, including protocol deviations.

·         Assist data management and trial management team in preparing for database lock.

6.       Perform Assigned QC Tasks to Ensure High Quality and Timely IWRS Services (Interactive Web-Based Response System, a Randomization and Drug Supply Management System):

• These QC tasks include, but are not limited to, the following: QC review of the IWRS user requirement documents and user acceptance test (UAT) plans and results, participate in the UAT processes, and ongoing monitoring of the IWRS applications.

7.       Complete job required and project-specific training. Comply with applicable Everest and trial sponsor’s policies, SOPs, and work instructions.

8.       Properly archive study files in accordance with trial sponsor’s requirements.

9.       Plan and carry out professional development activities. 

For new Biostatisticians to the company, SAS training in the local programming environment will be provided by the internal SAS programmers. Intensive SAS programming for statistical analysis and the generation of statistical TLGs will be a requirement for the first year on the job. Hands on key data management activities such as participation in the writing of Data Management Plans, reviewing of data queries, and cleaning up databases, will also be a requirement for the first year on the job.

MINIMUM HIRING REQUIREMENTS:

A Ph.D. degree in statistical science, mathematical analysis or related fields or a Master’s degree plus at least 2 years highly relevant experience, with demonstrated ability and sustained performance.