人才招募
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上海, 临床及注册 | 2020-05-11

统计程序员

Primary Function

The Statistical programmer/Senior Statistical Programmer is responsible for all statistical programming aspects at project level. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverable.

 

Responsibilities

  • Lead statistical programming activities at project level.
  • Co-ordinate activities of all programmers either internally or externally assigned to the study/studies. Make statistical programming recommendations at study level.
  • Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.
  • Review eCRF, discuss data structures and review activities as member of the Data Review Team.
  • Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans.
  • Provide input into statistical programming solutions and/or ensure their efficient implementation.
  • Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
  • Responsible for quality control and audit readiness of all assigned statistical programming deliverable as well as accuracy and reliability of statistical analysis results.
  • Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and training.
  • Develop company SAS macros and utilities.

 

Complexity

  • Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
  • Knowledge of statistical methodology

 

Specialized Knowledge

  • Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system
  • Good knowledge of CDISC standards including:
  • Study Data Tabulation Model (SDTM)
  • Analysis Data Model (ADaM)
  • Clinical Data Acquisition Standards Harmonization (CDASH)

 

Requirements

  • BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is required
  • At least 2-3 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmer
  • Positive working attitude

 

Preferred Requirements

  • Working experience in oncology projects
  • Self-management skills with a focus on deliverables
  • Project management experience