Manager, Statistical Programming

About the role

The Manager of Statistical Programming directs the statistical programming workflow from intake through final delivery. This role guides code integrity while partnering with Statistics and Regulatory teams. The manager sets standards so that clinical study outputs remain timely, accurate, and consistent. They own the end to end oversight of statistical programming activities ensuring that deliverables meet the highest standards of quality and regulatory compliance. This position is responsible for balancing project timelines with team capacity while maintaining a sharp focus on technical excellence. The manager champions continuous improvement initiatives that enhance the efficiency and robustness of statistical workflows. They act as a technical leader and strategic partner in the planning and execution of clinical study outputs across medical device and pharmaceutical projects.

Key facts

What you'll do

Set priorities for statistical programming intake while balancing project timelines and team capacity to meet critical study milestones. Architect analysis datasets and program logic for Tables, Listings, and Figures across diverse medical device and pharmaceutical studies. Champion programming standards, process documentation, and continuous improvement for statistical workflows to ensure scalability and reproducibility. Guide code verification and quality checks to ensure consistency across therapeutic areas and alignment with regulatory expectations and ICH guidelines. Interpret statistical analysis plans to shape dataset specifications and database design in close collaboration with study teams and data managers. Build solutions alongside cross-functional partners and manage CRO output to ensure timely clinical study delivery and integration with study databases. Maintain SAS, R, Python, and Git standards, including macro development, library management, and methodology sharing with technical staff to foster knowledge transfer. Monitor regulatory guidance, industry practices, and security compliance for programming conventions, output design, and data handling procedures. Estimate scope and effort for complex programming tasks while forecasting staffing needs for internal teams and external vendor resources to mitigate delivery risks. Represent clinical statistical programming in cross-functional forums where strategies, CRFs, and validation reports are shaped to ensure technical feasibility. Select, manage, train, and develop staff to build a high performing programming team that adheres to strict quality and ethical standards. Establish clear objectives and assignments and provide ongoing feedback through performance reviews, coaching sessions, and personalized development plans. Lead resource planning for the statistical programming team, including forecasting of employees and external resources such as contractors, temporary staff, CROs, and consultants to optimize workflow. Oversee team efforts related to derive data sets and programs, ensuring analysis data set specifications are met with precision and consistency. Ensure consistent analysis of data sets following appropriate standards for clinical studies and within therapeutic therapeutic areas to support regulatory submissions and internal reviews. Develop and oversee the development of statistical code for the creation of Tables, Listings, and Figures for clinical studies using advanced programming techniques. Ensure that all quality processes are followed rigorously, including peer reviews, unit testing, and validation checks to prevent defects. Determine the scope of code verification and ensure completeness of verification for assigned projects to maintain integrity and reproducibility. Provide input into the development of CRFs and database designs, and definitions to ensure data capture aligns with analytical requirements and regulatory standards. Participate in the development of CRFs, edit check specifications, and data validation reports to identify potential issues early in the study lifecycle. Participate in the review of Statistical Analysis Plans and Shells to ensure alignment with study objectives and regulatory expectations. Interpret the statistical analysis plans and develop analysis of dataset specifications to guide the programming strategy and data structure. Create documentation for regulatory filings, including reviewers guides, and data definition documents to support audit trails and regulatory inspections. Monitor and quantify efficiency, accuracy, and timeliness of the group using key performance indicators to drive productivity improvements. Ensure that appropriate concepts and techniques are implemented for clinical studies to address specific study designs and regulatory landscapes. Responsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions to maintain compliance and standards. Ensure efficient programming techniques are utilized by programmers to optimize processing time and resource utilization. Work collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects, and develop appropriate contingency plans to address risks. Lead the development of standard code (e.g., SAS, R, Python, Git) and standard operating procedures to create reusable assets and improve team efficiency. Maintain expertise in SAS macros and propose new macros to enhance productivity and automate repetitive tasks. Mentor others on existing macros to build internal capability and ensure knowledge retention. Oversee the development of new SAS macros focusing on modularity, scalability, and documentation to support broad application. Manage CROs and other outside vendors for statistical programming activities for clinical studies when appropriate for clinical study data analysis needs and study complexity. Oversee outsourced programming by providing ongoing reviews of activities and progress to ensure projects are delivered on time with suitable quality and adherence to contractual requirements. Adhere to the Company's Quality Management System, as well as domestic and global quality system regulations, standards, and procedures to ensure compliance and audit readiness. Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the company and clinical research operations. Ensure other members of the department follow the QMS, regulations, standards, and procedures through training, reviews, and continuous reinforcement. Perform other work-related duties as assigned to support organizational goals and strategic initiatives.

Requirements

Bachelor's degree in Statistics, Data Science, Computer Science, Mathematics, or a related field with 8+ years of experience or an equivalent combination of education and experience. In-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required to ensure study integrity and regulatory compliance. Candidates must demonstrate a strong understanding of clinical data structures, variable specifications, and dataset derivation principles. Proficiency in at least one major statistical programming language such as SAS, R, or Python is mandatory for this role. Experience with version control systems such as Git is required to manage code changes and facilitate collaborative development. The ability to interpret complex regulatory guidance and translate it into programming standards is essential for success in this position. Strong attention to detail is required to ensure accuracy in dataset creation, variable labeling, and output formatting for regulatory submissions. Excellent written and verbal communication skills are necessary to interact effectively with cross functional teams and external partners. Candidates must be able to manage multiple priorities in a fast paced environment while maintaining high standards of quality and meeting strict deadlines. Willingness to adhere to security and privacy rules protecting client and patient data is non negotiable for this role. The selected candidate must be authorized to work in the United States and be able to perform remote duties from a US home office without the need for business travel.

Nice to have

Master's or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or a related field with 6+ years of relevant experience to deepen technical expertise and mentorship capabilities. 1+ years of experience in a supervisory role desired to effectively lead teams and manage stakeholder expectations. Strong leadership and interpersonal skills are highly desired to foster collaboration and drive cross functional initiatives. Medical device, pharmaceutical, biotech, or other regulated industry experience desired to understand the specific challenges and regulatory requirements of these sectors. Regulatory filing experience preferred to ensure alignment with submission strategies and regulatory timelines. Experience with clinical trials, including familiarity with expectations of regulatory agencies such as the FDA and PDMA, preferred to ensure programming outputs meet regulatory standards. Ability to effectively represent the clinical statistical programming function in cross functional teams to ensure technical perspectives are integrated into study design and delivery. Ability to accurately estimate the effort and scope for programming activities to support resource planning and study feasibility assessments.

Practical notes

This role is external. Remote work from your US home office is expected. The schedule aligns with standard business hours; occasional after hours coordination may occur due to global project demands and urgent timelines. Travel is not required for this position as all responsibilities are conducted remotely. You must adhere to security and privacy rules protecting client and patient data, including compliance with HIPAA, GDPR, and other applicable regulations. This position is compensated at $130,000 per year for external contractors.