This is a fully remote position, open to applicants in South Africa, +4 more countries.

📋 Description

• Conduct data manipulation, analysis, and reporting of clinical trial information, focusing on safety and efficacy (ISS/ISE) through SAS programming.

• Create and validate SDTM and ADaM datasets, along with analysis files, tables, listings, and figures (TLFs).

• Execute production and quality control/validation programming tasks.

• Develop intricate ad-hoc reports utilizing raw data.

• Leverage a robust understanding and experience in efficacy analysis.

• Draft and review submission documents and electronic Case Report Tabs (eCRTs).

• Liaise with internal cross-functional teams and clients regarding project specifications, status updates, challenges, and inquiries.

• Assume lead responsibilities when required.

• Collaborate as a team member and adhere to deadlines.

• Adjust to shifting priorities.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related discipline.

• Minimum of 7+ years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech sector with a bachelor's degree or equivalent.

• A minimum of 6 years of relevant experience with a master's degree or higher.

• Proficient SAS data manipulation, analysis, and reporting abilities.

• Extensive experience in implementing CDISC SDTM / ADaM standards.

• Strong quality control and validation skills.

• Competent ad-hoc reporting capabilities.

• Expertise in efficacy analysis.

• Familiarity with the drug development lifecycle and the manipulation, analysis, and reporting of clinical trial data.

• Experience with submissions using define.xml and other necessary submission documents.

• Capability to prioritize tasks effectively.

• Excellent analytical and problem-solving skills.

• Ability to deliver high-quality output and results within tight deadlines.

• Capacity to work efficiently in a globally distributed team with cross-cultural colleagues.