Associate Director, Statistical Programing
About The Position
The Associate Director, Statistical Programmer will be responsible for performing data and statistical analysis in multiple clinical studies and collaborating with study statistician, data managers and the other functions in the clinical study team. In this role you will provide technical guidance on clinical project teams. Work is performed on the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. In addition, you will participate in departmental and cross functional technology development and process improvement initiatives.
Requirements
- A Master degree in Statistics, Mathematics, computer science or other equivalents.
- Minimum 8 years of SAS programming in a pharmaceutical, biotech or CRO setting.
- Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
- Strong hands-on SAS programing skills and working experience for clinical trial reporting
- Ability to handle multiple development programs simultaneously.
- Ability to be flexible and adapt quickly to the changing needs of the organization
- Strong interpersonal and effective communication (oral and written) skills
Responsibilities
- Serve as a Lead study programmer to support activities including review SAP, set up mock TFL, dry run, draft and final TFLs
- Collaborate with other functions for the requirement i.e. Safety update, publications etc.
- Effectively design and develop SAS programs including micros for efficiency and consistency
- May involve in the standardization and process improvement initiatives
- Supporting FDA submission as needed
- Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDlSC SDTM format; consistently meeting objectives of the study
- Performs quality control checks of SAS code and output produced by other Statistical Programmers
- Demonstrates proficient knowledge of clinical development and medical data
- Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision
- Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications
- Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry
- Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary time line constraints while assuring high quality standards
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Number of Employees
101-250 employees
