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* Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources, competing project priorities and client's expectations effectively. Ensure budget and scope of project work remain aligned.
* Apply advanced knowledge of CDISC standards and electronic data submission (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide, Analysis Results Metadata). Provide expertise and consultancy on FDA, PMDA and other regulatory agencies submission requirements.
* Take full ownership of department process improvement projects and initiatives including development of standard SAS Macros, in-house programming standards.
* Develop and provide Statistical Programmers, Biostatisticians and representatives of other departments and groups with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
Responsibilities
* Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources, competing project priorities and client's expectations effectively. Ensure budget and scope of project work remain aligned.
* Apply advanced knowledge of CDISC standards and electronic data submission (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide, Analysis Results Metadata). Provide expertise and consultancy on FDA, PMDA and other regulatory agencies submission requirements.
* Take full ownership of department process improvement projects and initiatives including development of standard SAS Macros, in-house programming standards.
* Develop and provide Statistical Programmers, Biostatisticians and representatives of other departments and groups with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
Requirements:
* Master's or bachelor's degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.
* Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
* 8+ Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries.
* Knowledge of statistics and exhibit routine and complex analytical skills.
* A focus on quality, accuracy, and completeness of work activities.
* Excellent communication skills.
* A good understanding of Good Clinical Practice.
* Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Information Technology
* Industries
Pharmaceutical Manufacturing
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