355190BR
Nov 17, 2022
Taiwan

Job Description

【Major Accountabilities】

Real World Evidence (RWE) Projects
- Analyze and propose data generation opportunities based on company/TA strategies, data gaps/ needs, and local regulations/requirements
- Provide inputs for potential data generation approaches to answered scientific questions and data gaps of interest
- Co-drive the development of RWE project concepts, protocols, and implementation plans in collaboration with the TA medical team
- Lead the IEP development for TAx products

Clinical Projects
- Liaise with and provide insights to statistical programmers assigned in support of study deliv-erables.
- Support project-level activities of clinical projects, includes study management and statistical & analysis plan development
- Track allocated project activities and milestones.
- Ensure and manage quality, timeliness, and efficiency for all support and deliverables for designated tasks.

Internal Novartis Tasks and Support
- Provide statistical scientific input for assigned clinical trials, comprising all relevant technical and disease area knowledge
- Follow processes and adhere to Novartis and project specific standards as well as Health Authority requirements (SOPs, GCP, and regulatory guidelines).
- Establish and maintain sound working relationships and effective communication within the local Trial Management Organization and internal and /or external Biostatistics team
- Collaborate with MSLs/ Medical Advisors/TA Medical Teams, Value & Access Teams and other cross-functional groups

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

【Education】
Required: MSc in Statistics (or equivalent degree/knowledge)

【Language】
Fluent in English & Local Language (oral and written)

【Experience】
1. 3+ years of RWE experience within the industry/consulting/payer organization.
2. Strong communication and interpersonal skills
3. Demonstrated ability to work collaboratively with cross-functional teams.
4. Knowledge/experience with SAS/ R/ S plus or any other business or research analytic software.
5. Understanding of multivariable models (cox, poisson, binomial and multinomial logistic, ANOVA and MANOVA and multivariate approach. (cluster discriminant, factor analysis)
6. Relevant medical/ clinical background
7. Experience in facilitating and optimizing trial designs and analysis strategies is a plus
8. Exposure to use of modern trial design/analysis methodologies is a plus
PHARMA
AMAC
Taiwan
Taipei City
Research & Development
Full Time
Regular
No
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355190BR

Medical Real World Data Manager

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