Manager, Statistical Programming

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.

Responsibilities

Select, manage, train, and develop staff; Lead a team of statistical programmers; Lead resource planning for statistical programming team; Oversee team effort related to derive data sets and programs, and analysis data set specifications; Ensure consistency analysis of data sets following appropriate standards; Develop and oversee development of statistical code for Tables, Listings and Figures; Ensure all quality processes are followed; Provide input into CRFs and database designs; Participate in review of SAP and Shells; Create documentation for regulatory filings; Monitor and quantify efficiency, accuracy, and timeliness; Ensure appropriate concepts and techniques are implemented; Monitor regulatory guidance and industry best practices; Ensure efficient programming techniques are utilized; Collaborate with stakeholders and propose solutions; Lead development of standard code and SOPs; Manage CROs and outside vendors; Adhere to the Company's Quality Management System.

Requirements

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.

Nice to have

Master's or higher degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience; 1+ years of experience in a supervisory role; Strong leadership and interpersonal skills; Medical device, pharmaceutical, biotech, or other regulated industry experience; Regulatory filing experience; Experience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA); 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; 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

Collaborative teamwork environment where learning is constant and performance is rewarded; Opportunity to be part of the team that is revolutionizing treatment of some of the world's most devastating diseases; Generous 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 per year, minimum of fifteen days of accrued vacation per year increasing with tenure, and paid sick time in compliance with applicable laws; Competitive compensation package plus benefits and equity program, when applicable.