Principal Statistical Programmer

**381891BR** **Job ID:** 381891BR **About the role:** Location: East Hanover, NJ #LI-Hybrid About the Role: This key role is responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities). The position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high-quality deliverables in Novartis Global Drug Development. Key Responsibilities: • Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium sized project in phase I to IV clinical studies in Novartis Global Drug Development. • Co-ordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level. • Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as member of the extended Clinical Trial Team (CTT). • Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. • Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. • Provide and implement statistical programming solutions; ensure knowledge sharing. • In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets. • Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications. • Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. \n\n\n\n **Position Title:** Principal Statistical Programmer **Role Requirements:** Essential Requirements: • BA/BS in statistics, computer science, mathematics, life sciences or related field • 5+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry • Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables • Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications • Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs • Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). • Good communications and negotiation skills, ability to work well with others globally • Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project Preferred Qualifications: • Master’s degree in statistics, computer science, mathematics or closely related field • Experience with R or Python preferred Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network The pay range for this position at commencement of employment is expected to be between $130,000 - $195,000; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition # in your message. **Job Type:** Full Time **Country:** USA **Work Location:** East Hanover, NJ **Functional Area:** Research & Development **Division:** Global Drug Development **Business Unit:** GCO GDD **Employment Type:** Regular **Company/Legal Entity:** Novartis Pharmaceuticals **Commitment to Diversity & Inclusion::** _The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential._ **Shift Work:** No **Early Talent:** No