Summary
About the Role
Major Accountabilities
1. Lead statistical programming activities as Trial Programmer for phase I to IV clinical studies or assigned project-level activities.
2. Co-ordinate activities of all programmers either internally or externally assigned to the study/project work. Make statistical programming recommendations at study level. Contribute to project level standards
3. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team (CTT).
4. Review eCRF, discuss data structures and participate in data review activities.
5. Comply with company, department and industry standards (e.g. CDISC) and processes, review and develop programming specifications as part of the analysis plans.
6. Provide input into statistical programming solutions and/or ensure their efficient implementation.
7. In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.
8. 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
9. Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
10. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
11. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
12. Contributes to assigned parts of process improvement, standardization and other non-clinical initiatives
Education (minimum/desirable):
BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related field
Languages:
Fluent English (oral and written).
Experience/Professional requirement:
1. Good SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables
2. Good experience in contributing to statistical analysis plans and/or constructing technical programming specifications
3. Good knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs
4. Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).
5. Good communications and negotiation skills, ability to work well with others globally
6. Proven ability to produce timely and quality deliverables under guidance (at least 1 year)
7. Ideally 4+years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry (2 years for MS Statistics/Computer Science graduates)
Why consider Novartis?
817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp
Japan
Novartis is 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 recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。
健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
利便性と合理的配慮
ノバルティス は 障害 を 持 つ 個人 と 協力 し、 合理的配慮 を 提供 することをお 約束 します。健康状態 や 障害 を 理由 に 採用 プロセス のいかなる 部分 においても、あるいは 職務 の 必須事項 を 果 たすた めに 合理的配慮 が 必要 な 場合 は [email protected] 宛 てに 電子 メール をお 送 りください。その 際 ご 依頼内容、 ご 連絡先、求人票 の 番号 を 明 してください。
