[上海]希奥莱姆医药科技咨询（上海）有限公司

JOB SUMMARY
Beginning SAS programmer who should have a clear understanding of clinical database structure and be able to produce basic
information from that database.

JOB RESPONSIBILITIES
- Assist in establishing departmental processes, interaction with other departments, training of staff, and other departmental
administrative tasks.
- Respond to non-statistical questions from Clinical Writing and from clients.
- Attend both client and team meetings when needed.
- Send tables and listings to clinical writers and clients, which includes printing, collating, and filling out appropriate shipping paperwork.
- Maintain tables and listings binders, if applicable, which includes a hard copy of the latest versions sent to the client.
- Create and maintain standard QC documentation.
- Coordinate QC project teams on large projects, which includes training and delegation of QC work.
- Write and compare independent QC programs to verify the output generated for data displays.
- Program routine data displays, such as data listings, in accordance with approved statistical analysis plan and shell displays for clinical
research studies. Code is to be written using Base SAS programs, SAS procedures, or standardized macros. Perform data checks as
needed to understand structure and content of data.
- Follow all pertinent SOP's and guidelines concerning programming and the change control management of all files generated by the
Biometrics Programming group.
- Must be able to use univariates, frequencies, Proc Transpose, and macros, including modifying existing macros and writing macros.
- Interact with Clinical Data Management (CDM) to resolve data issues.
- Review clinical data for outliers, invalid and illogical data points.
- Create and/or annotate and review tables and listings mocks; ensure internal consistency within and among tables and listings; ensure
that all CRF fields are displayed on listings.

KEY SKILLS &BEHAVIORS
- Work extensively with Biometrics project team members.

TRAINING AND EXPERIENCE
- 3 year computer science/math degree or equivalent; MS preferred.
- 0-2 years clinical programming or SAS programming experience.
- No special physical demands.

JOB SUMMARY -
Beginning Statistician who works to assist a senior person on analyzing a clinical data management database.

JOB RESPONSIBILITIES -
- Verify sample size determinations in protocol or statistical analysis plan for basic study design.
- Design randomization codes for basic clinical trials.
- Perform quality control of basic data displays that show inferential statistics.
- Prepare and annotate simple safety and efficacy shell data displays.
- Perform quality control of basic safety data displays analysis datasets.
- Help to maintain project directories on computer systems, including ensuring that final SAS output is in the correct directory and that all
interim programs and output are deleted at the completion of the project.
- Help to maintain project administration file, including protocol, annotated CRF, statistical analysis plan, annotated shells for data
displays, programming and quality control rules, tracking of generation and quality control of data displays, and project communication
(internal and client).
- Handle miscellaneous tasks as assigned by management.

KEY SKILLS &BEHAVIORS -
- Work with Biometrics project team members.
- Interact with other members of company project team.
- Assist in responding to client questions.
- Able to develop effective time management skills.
- Communication of data findings to the biometrics project team.

TRAINING AND EXPERIENCE
- Masters/PhD degree in Statistics/Biostatistics or equivalent discipline.
- 0-2 years of experience in the analysis of clinical data.
- No special physical demands.
- Major part of work done in office environment.
- Good knowledge of statistical procedure.
- High degree of accuracy and attention to detail.
- Good oral and written communication skill.
- Proficient in programming logic, experience with SAS preferable