Description

We are seeking an experienced and detail-oriented Senior Manager/Associate Director, Statistical Programming, to join our dynamic team. In this role, you will contribute to statistical analysis programming, focusing on the creation of SDTM and ADaM datasets, as well as the generation of tables, listings, and figures (TLFs) within the Biometrics group. You’ll be involved in the design, development, and quality control of SAS programs used to manage clinical trial data, supporting the submission of analyses for regulatory processes. Additionally, you’ll participate in technology development and process improvement initiatives within the department.

Company Culture and Environment

We value a diverse and inclusive work environment and encourage individuals from all backgrounds to apply. Our team thrives on collaboration and innovation, promoting a culture that supports professional growth.

Career Growth and Development Opportunities

This role offers significant potential for career advancement through participation in technology development and process improvement initiatives, allowing you to enhance your skill set and contribute to impactful projects within the organization.

Detailed Benefits and Perks

While specific benefits are not listed, the emphasis on professional development and a collaborative work environment suggests a strong focus on employee well-being and growth opportunities.

Compensation and Benefits

• Competitive salary based on experience
• Comprehensive health benefits
• Professional development opportunities

Why you should apply for this position today

This position is ideal for those passionate about statistical programming in the pharmaceutical industry. You will have the opportunity to lead programming efforts that impact clinical trial outcomes, all while working collaboratively in a diverse and inclusive atmosphere.

Skills

• Proficiency in SAS programming, including creating datasets, tables, figures, and listings for clinical trial results
• Strong understanding of CDISC, SDTM, and ADaM standards
• Familiarity with safety data and coding dictionaries like MedDRA and WHODRL
• Excellent written and verbal communication skills
• Strong organizational skills with the ability to manage multiple tasks and tight timelines
• Knowledge of software validation and system development life cycle concepts

Responsibilities

• Take the lead in programming tasks for assigned projects, ensuring timely and accurate delivery of data and results
• Manage project timelines and coordinate with both internal teams and external stakeholders
• Oversee vendor deliverables, ensuring quality and compliance with project objectives
• Design and code SAS programs for clinical studies, meeting study objectives and deadlines
• Develop SAS programs to analyze and report complex clinical trial data
• Contribute to New Drug Application (NDA), Marketing Authorization Application (MAA), and other regulatory submissions
• Perform quality control checks on advanced SAS code and statistical output generated by team members
• Identify and implement tools to improve the efficiency of the programming team

Qualifications

• Bachelor’s degree or higher in biostatistics, mathematics, statistics, computer science, life sciences, or a related field (Master’s degree preferred)
• A minimum of 4 years of experience in the pharmaceutical industry, focusing on statistical programming
• Experience in preparing documents and analyses for electronic submissions
• Strong analytical skills and capability to transform raw clinical data into required formats
• Experience with quality control of SAS code and output produced by others
• Familiarity with FDA and ICH regulations

Education Requirements

• Bachelor’s degree or higher in a relevant field

Education Requirements Credential Category

• Bachelor’s degree or higher

Experience Requirements

• Minimum of 4 years of relevant experience in the pharmaceutical industry
• Proven experience in statistical programming and regulatory submissions

Why work in Escondido, CA

Escondido, CA, is known for its beautiful weather, vibrant community, and diverse cultural offerings. The city provides a unique blend of urban amenities and natural beauty, with access to parks, recreational activities, and a variety of dining options. Working in Escondido allows for a balanced lifestyle, both professionally and personally.