Specialist I or II or Senior Specialist, Statistical Sciences in Japan Data and Statistical Sciences

Purpose Statement:

The position is responsible for providing support to Japan clinical development projects in the area of statistical sciences. The support is supplied in the context of a cooperative one team mindset project-oriented effort and included statistical capabilities in general planning and execution of clinical trials statistical analysis and reporting of the data from individual trials and regulatory submissions and inspections.

Major Responsibilities:

• Provide expertise to design analysis and reporting of clinical trials or other scientific research studies. Develop protocols and statistical analysis plan. Implement sound statistical methodology in scientific investigations.
• Perform statistical analysis as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines.
• Develop strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications including tables listings and figures.
• Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Partner with Data Science in preparing for database lock.
• Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions and pursue analyses suggested by data. Build/drive cross-functional relationships and collaboration.
• Support for dealing with the authorities. Perform follow-up and analysis of clinical study data based on requirements and comments from PMDA and support preparation of response.

Key Stakeholders:

• Statistical Sciences and Programming Group Manager
• Statistical Sciences Unit
• Clinical Development Experts
• Japan Development Project Lead

• PMDA

Key Stakeholders

• &

Qualifications :

Qualifications:

• At least 5 years of experience in pharmaceutical R&D including at least 3 years experience in data management and/or statistical sciences and programming areas.
• A bachelors degree in or equivalent knowledge of statistics/mathematics pharmacy biology pharmacology or related scientific field focused on quantitative skills. A masters or doctors degree is more favorable.
• Proficient in English communication skills (TOEIC 650 or more or equivalent)
• Good leadership skills as defined by AbbVie core leadership behaviors.

• Good fit with the ways we work as per below.

All4OneAbbvie - Interpersonal Savvy

Relates well to all kinds of people up down and sideways inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.

Decide Smart&Sure - Dealing With Ambiguity

Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isnt upset when things are up in the air; doesnt have to finish things before moving on; can comfortably handle risk and uncertainty.

Agile&Accountable - Managing Vision and Purpose

Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision shareable by everyone; can inspire and motivate entire units or organizations.

Clear&Courageous - Managerial Courage

Doesnt hold back anything that needs to be said; provides current direct complete and actionable positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation (not including direct reports) quickly and directly; is not afraid to take negative action when necessary.

Make Possibilities Real Planning

Accurately scopes out length and difficulty of tasks and projects; sets objectives and goals; breaks down work into the process steps; develops schedules and task/people assignments; anticipates and adjusts for problems and roadblocks; measures performance against goals; evaluates results.

Qualifications:

• 5
• 3
• /
• TOEIC650
• Abbvie core Leadership behavior

:

Remote Work :

No

Employment Type :

Full-time