Senior Statistical Programmer
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Cambridge, MA, US
Company:
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
Summary:
The Senior Statistical Programmer will support or lead clinical trials while performing data analysis and reporting using SAS. Candidates should possess extensive SAS programming experience and a bachelor's degree in a relevant field.
Requirements:
Technology: SAS
Hard Skills: SAS programming, CDISC standards (SDTM & ADaM), data manipulation, data analysis, clinical trial reporting
Credentials: Bachelor's degree in Statistics, Computer Science, Mathematics
Experience: At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry, At least 6 years of related experience with a master's degree or above
Job Description:
Job Description
Responsibilities:
- 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.
- Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/Client), utilizing SAS programming.
- Generating and validating SDTM and Adam datasets/analysis files, and tables, listings, and figures (TLFs).
- Production and QC / validation programming.
- Generating complex ad-hoc reports utilizing raw data.
- Applying strong understanding/experience of Efficacy analysis.
- Creating and reviewing submission documents and arts.
- Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries.
- Performing lead duties when called upon.
- 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.
Requirements:
- Bachelor's 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 bachelor's degree or equivalent.
- At least 6 years of related experience with a master's degree or above.
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Good ad-hoc reporting skills.
- Proficiency in Efficacy 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.