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Senior Statistical Programmer

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor's degree in Statistics, Computer Science, Mathematics, or Life Sciences, 8+ years of SAS programming experience in clinical trial data in Pharma/Biotech industry.

Key responsabilities:

Perform data manipulation, analysis, and reporting using SAS programming
Generate and validate SDTM and ADaM datasets/files
Create complex ad-hoc reports and submission documents
Communicate with internal teams and clients, serve as team player
Familiarity with drug development life cycle and rare diseases studies

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

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 eCRTs
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
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.
Experience supporting rare diseases and Gastro Intestinal studies would be a plus.
Excellent analytical & troubleshooting skills.

Requirements:

Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, and Life Sciences 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.
Study lead experience, preferably juggling multiple projects simultaneously preferred.
Strong SAS data manipulation, analysis and reporting skills.
Solid experience implementing the latest CDISC SDTM / ADaM standards.
Strong QC / validation skills.
Good ad-hoc reporting skills.
Proficiency in Efficacy analysis.
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.