As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.
How you will contribute:
* Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
* Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs)
* Production and QC / validation programming
* Generating complex ad-hoc reports utilizing raw data and analysis datasets
* Applying strong understanding/experience of Efficacy analysis
* Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
* Performing lead duties for assigned clinical study under principle programmers oversight
* Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
* Being adaptable and flexible when priorities change
* Generating and validating Non-CDISC transformation datasets and analysis datasets
* Proficient knowledge with SDTM/ADaM and TLFs. General expertise with Figures
* Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP.
* They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides.
* R complex macro writing are a plus
What you offer:
* Bachelors degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
* At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical Biotech industry with a bachelors degree or equivalent. At least 6 years of related experience with a masters degree or above.
* Study lead experience, preferably juggling multiple projects simultaneously.
* Strong SAS data manipulation, analysis and reporting skills.
* Strong QC / validation skills.
* Good ad-hoc reporting skills.
* Solid ADaM and complex TFL skills.
* Proficiency in efficacy analysis and survival analysis
* Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.
* Submissions experience utilizing define.xml and other submission documents
* Excellent analytical troubleshooting skills.
* Ability to provide quality output and deliverables, in adherence with challenging timelines.
* Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Please use the below link for job application and quicker response.
https://lifelancer.com/jobs/view/37c0ccf8d6e861968c61e0f4f503afad