Associate Director, Statistical Programming

Associate Director, Statistical Programming

The Associate Director, Statistical Programming, provides leadership for programming deliverables across one or more products within a therapeutic area. This role ensures the timely, accurate execution of clinical trial programming to support product development, regulatory approval, and market acceptance. The Associate Director collaborates cross-functionally within GSD (Biostatistics, Data Management, Medical Writing), as well as with external vendors.
This role leads multiple global projects involving cross-functional teams and outsourced resources, contributing to study design, analysis, and reporting, including programming rules and TLG specifications. The Associate Director drives consistency across compounds within a therapeutic area and leads process improvement and change management initiatives, proactively identifying risks and implementing mitigation strategies.
Responsibilities may include managing or mentoring programming staff, overseeing vendors or contingent workers, and supporting recruitment and talent development to build a high-performing team.
Key responsibilities include:
Leading programming activities to ensure quality and timely delivery across multiple projects
Supporting budget planning and resource allocation
Developing and enhancing programs, tools, and processes to improve efficiency and innovation
Overseeing CDISC-compliant submissions and developing SAS (or other statistical software) programs for dataset and TLG generation and validation
Reviewing key documents (e.g., protocols, SAPs) and contributing to data presentation plans and programming specifications (SDTM, ADaM)
Ensuring clarity, consistency, and adherence to standards across deliverables
Serving as a subject-matter expert on SOPs, regulatory requirements, and programming standards
Driving standardization of deliverables within and across therapeutic areas
Leading process and technology improvement initiatives and communicating risks and solutions effectively
Managing cross-functional collaboration to ensure data integrity and alignment
Promoting data visualization capabilities at the program level
Supporting hiring, training, and coaching efforts in partnership with leadership and HR
We offer a competitive benefits package, including:
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible, Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.