Associate Director of Statistical Programming - Remote, US

Salary Range: $195,000 - $210,000

Company Overview:

We are partnered with a global Clinical Research Organization which provides comprehensive clinical research services to pharmaceutical, biotechnology, and medical device companies. Their mission is to encourage excellence and innovation and are dedicated to accelerating the development of life-changing therapies for patients worldwide.

Position Overview:

We are seeking an Associate Director of Statistical Programming to lead and manage the statistical programming team, overseeing the development and execution of programming activities in support of clinical trials and regulatory submissions.

Key Responsibilities:

Leadership and Team Management:

• Provide leadership and direction to the statistical programming team, fostering a collaborative and high-performance culture.
• Mentor, coach, and develop team members to enhance their technical skills and professional growth.

Statistical Programming Oversight:

• Oversee the planning, execution, and validation of statistical programming activities for clinical trials, including analysis datasets, tables, listings, and figures (ADaM, TLFs).
• Ensure adherence to programming standards, best practices, and regulatory guidelines (e.g., CDISC standards, FDA/EMA guidelines).

Project Management and Collaboration:

• Serve as the primary point of contact for statistical programming activities, collaborating closely with cross-functional teams (e.g., Biostatistics, Data Management, Clinical Operations).
• Lead programming strategy discussions and provide input on study design, analysis plans, and data visualization techniques.

Quality Assurance and Compliance:

• Ensure the quality and integrity of programming deliverables through rigorous validation and quality control processes.
• Maintain compliance with regulatory requirements and internal SOPs, contributing to the development and implementation of best practices.

Qualifications:

• Bachelor's or Master's degree in Computer Science, Statistics, or related field.
• Strong experience in statistical programming within the pharmaceutical or CRO industry.
• Proficiency in SAS programming and familiarity with other programming languages (e.g., R, Python).
• Strong leadership and project management skills, with the ability to effectively manage multiple projects and priorities.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and clients.

Benefits:

• Competitive salary and comprehensive benefits package.
• Opportunities for professional development and advancement.
• Collaborative and dynamic work environment with a focus on innovation and excellence.
• Exposure to a wide range of therapeutic areas and clinical research projects.

Application Process:

Interested candidates should submit their resume/CV and a cover letter highlighting their relevant experience and qualifications to ethan@oculusgroup.com.