Your Main Responsibilities and Duties Include:
- Leadership and Project Management of statistical aspects of assigned project portfolio.
- Oversight and development of statistical and programming techniques to ensure quality and on time delivery of generated results, with a focus toward earning and retaining client confidence in statistical deliverables.
- Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization plans and schedules.
- Review and provide statistical input into the development of case report forms design, annotated case report forms and database documentation to ensure that SAS datasets will be consistent with trial design and CDISC standards.
- Author Statistical Analysis Plans (SAPs) for studies and/or project deliverables.
- Research, development and application of statistical methodologies and processes.
- Develop and/or review and provide input into SDTM and ADaM dataset specifications.
- Create table and listing shells per the SAP.
- Generate database listings for database QA audits.
- Assist data management and trial management team in preparing for database lock
- Write and/or supervise SAS programming and QC to create SDTM and ADaM data sets, tables, figures and listings for clinical study reports (CSRs).
- Perform statistical analyses of data and interpret results to ensure validity of conclusions.
- Collaborate with medical writer in the production, review and approval of integrated clinical study reports.
- Contribute to the regulatory submissions including development of Integrated Summaries of Safety (ISS) and Efficacy (ISE) including required data packages, documents and support for responses to regulatory questions.
- Interact with members of the Clinical Development Team to ensure a high level of client satisfaction through the successful execution of projects.
- Participate in Clinical Development Team meetings and client meetings when needed.
- Participate in departmental infrastructure building; experience developing and implementing programing standards/best practices, developing and maintaining SAS macro and program libraries, and managing/forecasting workload with the ability to prioritize work to support multiple trials.
To Succeed in this Position:
- You should have a Master's or Doctoral level degree in statistics with at least 5 years of experience performing statistical analysis and reporting for clinical trials.
- You should have a thorough understanding of the requirements of the management and analysis of clinical data as required by GCPs, FDA and ICH guidelines is essential.
- You should possess excellent problem solving, organizational, written and oral communication skills, the ability to manage multiple priorities and attention to detail is critical.
- You should have strong computer proficiency and SAS programming skills including experience implementing CDISC standards end-to-end are required.
- You will have the ability to perform statistical analyses of clinical data, prepare written interpretations of statistical results and to integrate these findings into clinical study reports and publications.
- You will have knowledge of core technical and regulatory requirements.
- You should have sound experience in the design, analysis and reporting of clinical studies.
- You will possess strong communication, collaboration and team working skills.
The most likely starting base pay range for this position is $120,000 to $140,000 per year. Several factors, such as experience, work location, skills, and business needs will determine an individual's exact level of compensation. Consideration will be given to experience that exceeds the listed requirements.
