Senior Principal Statistical Programmer

Job Description Summary

The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and belongs to the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum. In this role, you will be responsible for all statistical programming (SP) aspects of several studies, a medium to large sized program or program-level activities (incl. submission and post- marketing activities). You will be a key collaborator and strategic partner with cross-functional team members within the clinical trial / program, ensuring the integrated / clinical development / evidence plans are executed efficiently with timely and high-quality deliverables.

Job Description

Your Key Responsibilities :

Lead statistical programming activities as a trial programmer for one or multiple trial(s) or as a lead / program programmer for a program or an indication.

May coordinate activities of internal / external programmers. Make SP decisions and propose strategies at study, program or indication / disease level.

May act as functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes.

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 statistical programming representative in study- or program-level team.

Review eCRF, data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production.

Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies).

Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects.

Ensure timely and quality development and validation of datasets and outputs for clinical study reports (CSRs), regulatory submissions / interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies / program.

Responsible for quality control and inspection readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.

Maintain up-to-date advanced knowledge of programming software (e.g. SAS, R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml). May act as subject matter expert (SME) on process improvement / non-clinical initiatives with a focus on programming

Video Link https : / / www.youtube.com / watch?v=vUAhCMIZbys

This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely.

Role Requirements :

Essential Requirements :

BS / MS degree in statistics, computer science, mathematics, life science or equivalent relevant degree and 7+ years of work experience in a programming role preferably supporting clinical trials / or in pharmaceutical industry

Experience as Trial / Lead / Program Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study / program, ability to transfer own knowledge to others

Expert SAS / R experience and proven skills in the use of SAS / R within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs

Advanced experience in contributing to statistical analysis plans and / or constructing technical programming specifications.

Advanced 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)

Proven communications and negotiation skills, ability to work well with others globally and influence

Desired Requirements :

Working knowledge of R is desirable, though not essential.

Novartis Compensation and Benefit Summary :

The salary for this position is expected to range between $119,700 and $222,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here .

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

You'll receive :

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

https : / / www.novartis.com / careers / benefits-rewards

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 number in your message.

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

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$119,700.00 - $222,300.00

Skills Desired

Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis