Manager, Statistical Programming

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

📋 Description

• Oversee a team of statistical programmers involved in clinical research activities for medical devices.

• Offer statistical programming assistance across various projects.

• Foster relationships and encourage collaboration among different functions.

• Guarantee the quality, integrity, and timely delivery of programming outputs that support clinical studies, publications, and regulatory submissions.

• Propel programming standards, process enhancements, innovations, and ongoing improvements.

• Recruit, manage, train, and develop team members.

• Direct resource planning for the statistical programming team.

• Supervise the team's efforts related to deriving data sets and programs, as well as analysis data set specifications.

• Ensure consistent analysis of data sets in accordance with established standards for clinical studies.

• Create and oversee the development of statistical code for clinical research.

• Ensure adherence to all quality processes.

• Contribute insights into the creation of CRFs and database designs.

• Take part in the evaluation of SAP and Shells.

• Generate documentation for regulatory submissions.

• Track and assess the efficiency, accuracy, and timeliness of the team.

• Ensure the implementation of appropriate concepts and techniques for clinical studies.

• Collaborate effectively with various stakeholders and devise suitable contingency plans.

• Lead the development of standard codes (e.g., SAS, R, Python, Git) and standard operating procedures.

• Manage CROs and other external vendors for statistical programming tasks when necessary.

⛳️ Requirements

• Bachelor's degree in Statistics, Data Science, Computer Science, Mathematics, or a related field with over 8 years of experience or an equivalent combination of education and experience.

• Comprehensive understanding of statistical programming concepts and techniques relevant to medical devices or drug development is essential.

• A Master's degree or higher is preferred in Statistics, Data Science, Computer Science, Mathematics, or a related field with at least 6 years of pertinent experience.

• A minimum of 1 year of experience in a supervisory capacity is desired.

• Strong leadership and interpersonal skills are highly sought after.

• Experience in medical devices, pharmaceuticals, biotechnology, or other regulated industries is preferred.

• Familiarity with regulatory filing is advantageous.

• Experience with clinical trials, including knowledge of regulatory agencies' expectations (e.g., FDA, PDMA), is preferred.

• Ability to effectively represent the clinical statistical programming function within cross-functional teams.

• Capable of accurately estimating the effort needed for project-related programming tasks.

• High level of technical proficiency and communication skills, both verbal and written.

• Knowledge of ICH guidelines and relevant regulatory standards.

• Excellent problem-solving capabilities, with a proven ability to guide programmers.

• Strong organizational skills with the capability to prioritize tasks while managing multiple projects concurrently.

• Exceptional accuracy and attention to detail.

• Proficient in statistical programming and macro development.

🏝️ Benefits

• A collaborative team environment where continuous learning is encouraged, and performance is recognized.

• The chance to be part of a team that is transforming the treatment of some of the world’s most challenging diseases.

• A comprehensive benefits package for eligible employees, including medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays annually, a minimum of fifteen days of accrued vacation per year that increases with tenure, and paid sick leave in compliance with applicable laws.