Manager, Statistical Programming

About this role

General Summary The Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager of Statistical Programming 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.   Specific Duties and Responsibilities •    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. * •    Creation 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. *Indicates an essential function of the role   Required Qualifications Minimum education and experience: •    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. Preferred Qualifications: •    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.   Working Conditions •    General office environment. •    Willingness and ability to work on site. May have business travel from 5% - 10%. •    Requires some lifting and moving of up to 10 pounds. •    Must be able to move between buildings and floors. •    Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. •    Must be able

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