Principal Statistical Programmer

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

📋 Description

• Collaborate closely with a pharmaceutical client while receiving support from Cytel.

• Operate autonomously with conceptual guidance and minimal supervision.

• Monitor progress and provide expert technical assistance to team members.

• Engage in clinical development programs across various therapeutic areas.

• Take part in managing CRO programmers to ensure the delivery of consistent, high-quality data summaries.

• Execute reporting and analytical tasks for sponsor clinical trials.

• Create SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies.

• Develop SAS programs that produce datasets, complex listings, tables, descriptive and inferential statistics, and intricate graphs.

• Design, validate, and maintain SAS and/or R programs tailored to clinical development initiatives.

• Supervise CRO statistical programming outputs for various clinical studies and ensure deadlines are adhered to.

• Assist with clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses.

• Adhere to FDA regulations, good clinical practices, and electronic submission standards.

• Establish, maintain, document, and validate standards for programming tools, outputs, and macros.

• Participate in CRF development, edit check specifications, and data validation plans.

• Review and/or draft data transfer specifications for external vendor data.

• Collaborate with CROs, software vendors, clinical development partners, and internal teams.

• Review and/or create SOPs and work instructions pertaining to statistical programming.

⛳️ Requirements

• A minimum of a bachelor’s degree in computer science, data science, mathematics, or a preferred statistics major.

• Over 7 years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or a similar group.

• Experience in supporting drug development, medical device development, or intervention studies.

• Exceptional SAS programming capabilities and expertise in the development and execution of statistical programming procedures and processes within a clinical development framework.

• Extensive practical experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations.

• Experience in supporting regulatory submissions and engaging with the FDA and/or global regulatory authorities.

• Ability to work independently is essential.

• Excellent written and verbal communication skills, along with strong leadership abilities.

• Preferred: previous work experience with pharmacokinetic data and in the neuroscience sector.

• Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, or git.

🏝️ Benefits

• Ongoing training, development, and support.

• Opportunities for significant professional growth.

• Professional growth prospects through staff development.