Associate Director, Statistical Programming

Teva Pharmaceuticals • West Chester, IA

18d

About The Position

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. 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.

Requirements

• Bachelor's degree required
• A minimum of 10 years of experience of statistical programming experience in clinical trials
• Experience with SAS required
• Direct experience with CDISC standards (SDTM, ADaM)
• Experience supporting regulatory submissions (e.g., FDA, EMA)
• Expert level of programming skills and problem resolution in SAS or other Statistical programming software
• Expert knowledge of CDISC data standards and implementation
• Expert understanding of statistical concepts
• Expert understanding and ability to resolve Pinnacle 21 report findings
• Expertise working with eCTD submission packages and define.xml creation
• Expertise with multiple regulatory submissions (e.g., FDA, EMA)
• Leads programming procedural documents (SOPs, work instructions and job aids) development
• Exceptional knowledge of government regulations pertaining to drug development in multiple therapeutic areas
• Expert understanding of clinical data structures (e.g. CDISC)
• Expert understanding of statistical concepts used in analysis and submission of clinical trial data
• Guide and represent Clinical Programming in healthcare authority inspections

Nice To Haves

• Master's or advanced degree preferred
• Preferrably in computer science or statistics or related field
• R preferred

Responsibilities

• 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

Benefits

• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees