Associate Director, Statistical Programming

Teva Pharmaceuticals

West Chester, PA

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JOB DETAILS

SKILLS

Analysis Skills, Biostatistics, Biotech and Pharmaceutical, Budget Management, Career Development, Change Management, Clinical Data, Clinical Data Interchange Standards Consortium (CDISC), Clinical Trial, Coaching, Compensation and Benefits, Computer Programming, Computer Science, Cross-Functional, Data Management, Data Quality, Data Sets, Data Structures, Data Visualization, Drug Development, Equal Employment Opportunity (EEO), FDA (Food and Drug Administration), Government Regulations, Healthcare, Hospital, Immunology, Insurance, Leadership, Legal, Medical Conditions, Medical Genetics, Medical Writing, Medicine, Mentoring, Military, Multitasking, Neuroscience, Outsourcing, Physical Therapy, Pinnacle, Prescription Drugs, Problem Solving Skills, Procedural Programming Languages, Process Improvement, Product Development, Product Programs, Product Support, Project/Program Management, R Programming Language, Regulations, Regulatory Requirements, Regulatory Submissions, Resource Management, Resume Search, Risk Analysis, Risk Management, Software Engineering, Standard Operating Procedures (SOP), Statements on Auditing Standards (SAS), Statistical Analysis System (SAS), Statistical Programming Languages, Statistics, Statistics Software, Stock Purchase Plans, Talent Management, Time Management, Tuition Fees, XML (EXtensible Markup Language)

LOCATION

West Chester, PA

POSTED

30+ days ago

**We Are Teva** 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. **Our Team, Your Impact** **Position Summary:** 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 **Your Skills and Experience** Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Education/Certification/Experience + Bachelor's degree required + Master's or advanced degree preferred + Preferrably in computer science or statistics or related field + A minimum of 10 years of experience of statistical programming experience in clinical trials + Experience with SAS required, R preferred + Direct experience with CDISC standards (SDTM, ADaM) + Experience supporting regulatory submissions (e.g., FDA, EMA) Skills/Knowledge/Abilities: + 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. **How We’ll Take Care of You** 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.   **Already Working @TEVA?** Make sure to apply through our internal career site on Twist—your one-stop shop for career development **Teva’s Equal Employment Opportunity Commitment** Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to AskHR@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. **Important notice to Employment Agencies - Please Read Carefully** Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. EOE including disability/veteran

About the Company

Teva Pharmaceuticals

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