Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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