Senior Statistical Programmer, FSP

This is a fully remote position, open to applicants in India.

📋 Description

• Conducting data manipulation, analysis, and reporting on clinical trial data, including safety and efficacy (ISS/ISE), using SAS programming.

• Creating and validating SDTM and ADaM datasets/analysis files, as well as tables, listings, and figures (TLFs).

• Engaging in production and quality control/validation programming.

• Developing complex ad-hoc reports utilizing raw data.

• Applying a robust understanding and experience in efficacy analysis.

• Drafting and reviewing submission documents and electronic Case Report Tabs (eCRTs).

• Interacting with and responding to internal cross-functional teams and clients regarding project specifications, status updates, issues, or inquiries.

• Taking on lead responsibilities when necessary.

• Acting as a collaborative team member, demonstrating a commitment to achieving results and meeting deadlines.

• Being adaptable and flexible in response to changing priorities.

⛳️ Requirements

• A bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.

• A minimum of 6 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent; at least 4 years of relevant experience with a master’s degree or higher.

• Experience as a study lead, ideally managing multiple projects at once.

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

• Strong background in implementing the latest CDISC SDTM / ADaM standards.

• Excellent quality control/validation capabilities.

• Competent in ad-hoc reporting.

• Expertise in efficacy analysis.

• Familiarity with the drug development life cycle and experience in the manipulation, analysis, and reporting of clinical trial data.

• Experience with submissions including define.xml and other related documents.

• Background in supporting immunology, respiratory, or oncology studies is a plus.

• Exceptional analytical and troubleshooting skills.

• Proven ability to deliver quality outputs and deliverables while adhering to challenging timelines.

• Capability to work effectively and successfully within a globally dispersed team environment alongside cross-cultural partners.

🏝️ Benefits

• At Cytel, we are committed to the success of our employees and facilitate this through ongoing training, development, and support.