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10 Feb 2016

Full-Time Senior Statistician/Statistician (>$100/year) @ Shinjuku-ku, Tōkyō-to, Japan

BJ Shinjuku-ku, Tōkyō-to, Japan

Job Description

The statistician has accountable for all statistics within the designated projects and trials.
In order to provide our excellent products with high values on market first, the statistician has a responsibility to optimise the clinical development plan (CDP) statistically, and complete the CDP, protocol, statistical analysis plans (SAP), data handling, clinical trial report (CTR), common technical document (CTD) and regulatory documents statistically within the designated projects and trials.

1.(Senior Statistician60%/Statistician75%)
Accountable for all statistics within the designated projects and trials

Complete CDPs and protocols statistically
・to support in preparation of design, objectives, randomisation, endpoints and so on
・to prepare the chapter of “Statistical Consideration” (sample size, endpoints, hypotheses, data handling and analysis policy)

Prepare the quality SAP
・to prepare the SAP including the table shells in accordance with the protocol before database lock (DBL) in accordance with SOP, guidelines and projects standards

Design the derived data set / To complete the data handling statistically
・to prepare the definition tables of the derived data sets
・to support in preparing of the DBL meeting material from the statistical viewpoint
・to ensure that the derived data set reflects the data handling agreements

Prepare the analysis programs and the analysis report
・to prepare the analysis programs with programmer in accordance with the SAP before DBL
・to execute the programs after DBL and to confirm the outputs/results
・to prepare the section 14 and 16.2 in CTR as statistical outputs and to prepare analysis report or memo if necessary.
・to hold result meeting

Complete the CTR and the CTD statistically and to answer the questions from authority
・to support CTR preparation concerning statistical matters
・to prepare tables, figures and listings for CTD
・to describe a part of CTR/CTD or to support CTR/CTD preparation concerning statistical matters
・to answer the questions related to the statistics from authority

(Senior Statistician 2.20%/Statistician 10%)
Responsible for sharing better practices and increasing awareness of statistics within the designated projects and also development division
・promote statistical thinking, increasing awareness of statistical practices and ideas within the designated projects and development division
・carry out and advice on complex and technically demanding statistical tasks and act as senior expert consultant in relation to high profile problems such as complex regulatory issues or innovative designs
・maintain and improve scientific statistical knowledge

(Senior Statistician 3.10%/Statistician 0%)
Responsible supervise and coaching of less experience statistician
・to collaborate with group manager to support the development of less experienced statistician
・to scientifically supervise and coach less experienced statistician
・to identity need for additional training and education of less experienced statistician

(Senior Statistician 4.5%/Statistician 5%)
To be in charge of a part of the standardisation and globalisation of the statistical activities
・to participate in international statistical meeting to discuss SOP, global standards etc.
・to perform the standardisation activities
・to facilitate globalization

(Senior Statistician 5.5%/Statistician 10%)
Responsible for continuous development of own skills according to individual development plan (IDP)
・maintain and improve statistical knowledge
・identity the needs for additional training and education
・improve English communication skill

How to Apply

If you are a native Japanese speaker, please feel free to contact: [email protected]  

Job Categories: Data Scientist / Statistician. Job Types: Full-Time. Salaries: More than $100,000.

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