VACANCY
Statistician: Mid-Senior level, Remote, USA
- At least a Bachelor’s degree (or equivalent) in mathematics, statistics, or related disciplines.
- Good knowledge of statistical software (at least SAS® or R).
- At least 5 years of experience in the biometry department of the pharmaceutical industry or clinical research organizations or University as a statistician in Biostatistics.
- At least 2 years of experience in SAS.
- Knowledge of CDISC standards (SDTM, ADaM).
- Knowledge of international clinical research regulations and requirements.
- Ability to manage international situations, liaise with sponsors and external stakeholders, and communicate clearly and effectively.
- English language fluent.
- Excellent planning, organizational skills, and attention to detail.
- Strong communication and teamwork skills.
- Inform and suggest solutions to the statistics head on critical issues within the project.
- Discuss protocol and CRF with the authors and members of the project team (when required).
- Collaborate in the writing of the statistical section of the protocol (if asked to) stating the hypothesis, defining the planned analysis, primary and secondary endpoints, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
- Plan details of the randomization schedule with the appropriate members of the project team (if required).
- Document methods and procedures used in the analysis in a detailed SAP.
- Plan and direct or perform the programming for the protocol specific data report and statistical evaluations. Assist in programming and/or validation where appropriate.
- Discuss and plan model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the project team.
- Perform standard and special analyses and provide the appropriate members of the project team with listings, summary tabulations and graphics.
- Participate in the writing of the statistical section/module of reports (FSR, integrated safety/efficacy reports and publications).
- Maintain up-to-date project documentation including presentation, analysis and graphics software.
- Verify adherence to statistical standards and SOPs within the project.
- Provide technical advice and support to other project team (statistician in particular) members.
- Assess, recommend and develop new standards, policies and procedures.
