Manager, Statistical Programming

Role Description

The Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager provides statistical programming support for multiple projects through own efforts and those of staff for assigned projects. The manager builds relationships and promotes collaboration across functions with internal colleagues in Statistics, Data Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management. This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. The role drives programming standards, process improvements, innovations, and continuous improvement.

• Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Lead a team of statistical programmers. Attract, recruit, hire, and retain new staff.
• Lead resource planning for statistical programming team, including forecasting of employees and external resources (contractors, temps, CRO, consultants).
• Oversee team effort related to derive data sets and programs, and analysis data set specifications.
• Ensure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.
• Develop and oversee the development of statistical code for the creation of Tables, Listings and Figures for clinical studies.
• Ensure that all quality processes are followed. Determine the scope of code verification and ensure completeness of verification for assigned projects.
• Provide input into the development of CRFs and database designs, and definitions. Participate in the development of CRFs, edit check specifications, and data validation reports.
• Participate in the review of SAP and Shells. Interpret the statistical analysis plans and develop analysis of dataset specifications.
• Create documentation for regulatory filings including reviewers, guides, and data definition documents.
• Monitor and quantify efficiency, accuracy, and timeliness of the group.
• Ensure that appropriate concepts and techniques are implemented for clinical studies.
• Responsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions.
• Ensure efficient programming techniques are utilized by programmers.
• Work collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects, and develop appropriate contingency plans.
• Lead the development of standard code (e.g., SAS, R, Python, Git) and the development of standard operating procedures. Maintain expertise in SAS macros and propose new macros. Mentor others on existing Macros. Oversee the development of new SAS Macros.
• Manage CROs and other outside vendors for statistical programming activities for clinical studies when appropriate for clinical study data analysis needs. Oversees outsourced programming by providing ongoing reviews of activities and progress to ensure projects are delivered on time with suitable quality.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department to follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Qualifications

• Bachelor’s degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 8+ years of experience or equivalent combination of education and experience.
• In-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required.

Requirements

• Master’s or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience.
• 1+ years of experience in a supervisory role desired.
• Strong leadership and interpersonal skills are highly desired.
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired.
• Regulatory filing experience preferred.
• Experience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred.
• Able to effectively represent the clinical statistical programming function in cross functional teams.
• Able to accurately estimate the effort required for project related programming activities.
• High degree of technical competence and communication ability, both oral and written.
• Understanding of ICH guidelines and relevant regulatory requirements.
• Excellent problem-solving skills, with a demonstrated ability to guide programmers.
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
• High degree of accuracy and attention to detail.
• Competent in statistical programming and Macro development.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).