高级SAS编程经理-药物临床试验

Summarizes the job’s purpose or role an******** it exists in theorganization
SAS Programming Team in the department of Statistics ofHengru********&D Center provides clinical programming support forvarious clinical studies an******** to the development of departmentalstandards. Senior Manager of SAS Programming is accountable forprogramming team deliverables for the assigne******** projects. Thisrole is that of a programming lea******** plans an******** oversight ofSAS programming activities (e.g., ******** verification an********) insupport of clinical trial reporting an********.

NATURE & SCOPE

a) Organization Structure
Report to: Hea******** Statistical Programming
Number of Subordinate******** TBD
b) Key Working Relations
Communicates with statistician an******** manager to fullyunderstan******** requirements for assigne******** projects, leads theprogramming team to perform all SAS programming tasks with high qualityin the agree********, an******** closely with data management to assuredata ******** sometimes needs to interact with projec******** manager onperiodic trial management reports.

JOB REQUIREMENTS
Academic / Professional Qualification
- Minimum of a Bachelor’s degree in Stat******** Mathemat********Computer Sc******** Pharmaceuticals Sc******** Life Sc******** PublicHealth or other relate********. Master's Degree is preferred.
- In-depth knowledge of SAS programm******** stat******** clinical drugdevelopment process an******** requirements relate******** the role.

Technical / Skills Training
- In-depth knowledge of Base SAS, SAS/STAT, SAS Graph, SAS SQLan******** Macro Language. SAS Certification is preferred, not required.
- Basic knowledge to use Windows Operating System, an******** Office(Word, Excel, PowerPoint an********). Knowledge of Visual Bas********Java, Python or Perl programming language is preferred.
- Effective communication skills an******** to establish an********effective working relationships with study team members. Being fluent inspoken an******** English.
- Thorough understanding of relational database components an********.
- Sol******** an******** solving skills paire******** strong attentionto detail.
- Must be a mot******** self-directe******** with a passion an********for technology.
- Ability to work under pressure an******** multiple projectssimultaneously.


Working Experience
- Minimum of 7 years of proven experience in SAS programming.Pharmaceutical/Clinical trial experience is required.
- Must have at least 2 years of experience of mentoring juniorprogrammers.
- In-depth knowledge of analysis requirements for endpoints in multipletherapeutic areas (TAs), oncology TA experience is highly desirable.
- Experience working with external vendor******** is desired.
- Knowledge of relevant internal an******** standards an******** forclinical development (CDISC, EMEA/FDA, ICH-GCP etc.)
- Fully accountable for the programming work.

DUTIES & RESPONSIBILITES
Key Tasks
- Participates in review of protocol, statistical analysis plan (SAP),data integrity plan (DIP), data management plan (DMP) an******** reportform (CRF).
- Participates in creation of programming documents including list oftables, mock tables, analysis spec******** dataset specificationsan******** relate********, an******** all programming-relate******** arein the appropriate location on the company server.
- Is accountable for the production of high-******** on-time statisticalprogramming deliverables (such as datasets an**************** (TLFs))for either outsource******** insource******** studies an********programs.
- Works with data management to perform data quality checks.
- Ensures clear an******** communications with study team members.
- Ensures all programming activities following regulatory requirementsan******** SOPs.
- Mentors new hires or provide training to SAS programmers.
- Participates in the development an******** of programming tools fordata analysis an********.
- Contributes to development of programming relate********.
- Provides regular oversight of statistical programming workoutsource******** programming vendor******** an******** as a liaisonbetween the vendor/CRO an******** Hengru******** an******** function.