General Information

Job Advert Title: Data Management Systems Principal Programmer

Location: Nihonbashi, Tokyo

Division: Data Science

Employment Class: Permanent

Description

Purpose & Scope

The Principal Data Management (DM) Systems Programmer develops, manages and supports data management (and related) systems (e.g., EDC, reporting and visualization tools, coding tools) used to collect, review, and clean data in Astellas’s phase I-IV clinical trials. The Principal DM Systems Programmer will actively search for solutions which reduce study set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.

The Principal DM Systems Programmer provides technical excellence to Data Management to standardize and streamline review and cleaning of data received through other routes than the EDC system by developing appropriate tools and data standards. The individual oversees and/or provides technical support to Data Management and/or CRO to collect and check data received from external providers (e.g., central laboratories, ECG laboratories, and Biopharmaceutical laboratories).

The Principal DM Systems Programmer has strong IT/systems background and experience, combined with breadth of experience through support of multiple drug development teams and customer stakeholders. The Principal DM Systems Programmer may represent Astellas in external industry collaborations and process improvement discussions, with a focus on networking discussions on best practices.



Essential Job Responsibilities

Ability to develop and/or assist team members to build, deploy, debug, and manage the overall use of analytic visualizations and reports using tools like Qlik and/or eClinical Solution.

Ability to design, develop, test, and deploy highly efficient SQL code and data mapping code according to specifications.

Work with developers, other team members and users to review the business requirements and translate them into visualizations and reports.

Creates, reviews and approves technical specifications for data management systems. Develops complex programs and/or technical solutions per technical specifications.

Seeks to make continual improvement to processes and templates used to create technical specifications.

May develop complex reports using JReview, Business Objects, Crystal Reports, etc. Troubleshoots and resolves report issues.

Responsible for the implementation and maintenance of assigned data management systems and all associated processes and standards to support and improve them.

Helps end users understand the challenges before them, analyzes/understands the current state/process to ensure that the context/implications are understood by them and needs and expectations are represented correctly in the final solution.

Has expertise to work with end users and technical teams with ease to translate user requirements into workable solutions using the available systems/technologies



Organizational Context

Reports to Associate Director/ Director, DM Systems.

Contributes subject matter expertise to study teams, as needed.

Independent worker, working under loose supervision of Line Manager.

Closely collaborates with cross-functional study team members (e.g., Data Manager, Study Manager, Clinical Programmer, etc.) or other cross-functional staff such as procurement, systems and IT staff as appropriate.

Interacts with counterparts globally and is expected to provide focused support to all global DS team members, as driven by business need.



Required

BS or MS degree in Computer Science, Informatics, or life science discipline; minimum of 6 years in pharma or CRO industry in an informatics or programming role.

Experience using SQL code and data mapping code.

Experience using Crystal Reports, Business Objects and other business intelligence tools.

Solid understanding of relational database structure.

Demonstrated experience using Medidata Rave (or similar EDC system) from a front end data management user perspective. Back end user knowledge of Medidata Rave is desirable.

Demonstrated experience in leading system selection and implementation projects.

Previous experience in supporting inspections and major (vendor) audits.

Strong cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical, with high level of expertise expected in the DM systems discipline.

Strong computer skills, including database management software, reporting tools, medical coding tools, etc.

Excellent verbal and written communication skills.

Proven ability to work with and influence individuals across multiple disciplines in international environment.

Strong project management and organizational skills in order to prioritize work for self and others to ensure timelines are met, oversee activities of multiple studies.

In-depth knowledge of the drug development and data management processes.

Very good knowledge of international regulations for clinical trials (e.g. GCP).

Ability to communicate effectively and maintain effective relationships. Must be able to influence staff in other Astellas groups.



【勤務地 / Location

東京都中央区 アステラス製薬 日本橋事業所 本社

Nihonbashi, Tokyo



【勤務開始日 / Start Date

応相談

Will be decided according to the candidate's flexibility



【契約期間 / Contract Duration

期間の定めなし

Not limited to specified period



【試用期間 / Probation Period

試用期間原則なし

No probation period in principle



【給与 / Salary

①基本給:当人の経歴・技術・技能等を考慮して決定

②裁量労働制の場合:裁量労働手当として職務グレードに応じて50,000100,000円支給

③フレックスタイム制の場合:月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給

①Base salary: will be decided by the candidate's experience, skill and capability.

②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000~100,000yen, based on the Grade)

③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.



【昇給 / Salary Raise

年一回

Once a year



【賞与 / Bonus

2回(7月、12月)

Twice a year (July, December)



【諸手当 / Allowance

裁量労働手当、住宅手当、通勤手当 等

Discretionary work allowance, Housing allowance, Commutation allowance, etc.



【勤務時間 / Working Hours

8:45~17:45(月~木)、8:4516:00(金)、専門業務型 裁量労働制

裁量労働制の場合、所定労働時間を働いたものとみなす

8:45~17:45MonThu)、8:4516:00Fri

Discretionary Work System



【休日 / Holidays

完全週休2日制、祝日、51日、夏季、年末年始

Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays



【休暇 / Vacation Leave

年次有給休暇、育児休業制度、介護休業制度 等

Annual paid leave, childcare leave system, nursing care leave system, etc.



【福利厚生 / Welfare

雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等

Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System



【お問い合わせ / Contact

アステラス製薬株式会社 採用担当 / Japan Recruiting team, Astellas Pharma Inc.

astellas.recruit@jp.astellas.com

※本職種についてのご質問は、上記までお問い合わせください。


"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.