会社

Astellas Pharma続きを見る

address住所Tokyo, Nihonbashi
type 仕事の形態Permanent

仕事内容

【募集の背景 / Purpose & Scope】
The primary purpose of Associate Manager, Statistical Programming is to perform at the study level under the supervision of Global Programming Lead (GProgL) or a delegate, producing and providing quality control over tables/listings/figures (TLFs) as a part of the Data Science programming team. In addition, this position contributes to functional/departmental infrastructure projects. This position is expected to complete work related tasks with an appropriate level of independence and in accordance with the project direction and standards.

【職務の内容 / Essential Job Responsibilities】
(Immediately after hiring)
• Contributes to the production of high-quality, on-time Statistical Programming assigned deliverables (such as datasets and tables/listings/figures) related to clinical/observational studies including post hoc, HTA, regional, PK-PD or Biomarkers analyses.
•  Works in collaboration with the internal programming team or with the lead at the vendor.
• Follows Astellas, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards).
• Responsible for efficiently communicating, at regular intervals, to functional management on study/project/initiative status and resource issues.

(Scope of change)
All operations within the company

【組織 / Organizational Context】
Part of the Data Science Division (DS), Statistical & Real World Data Science (SRS) is a global, diverse, comprehensive and inclusive group of quantitative scientists who design Astellas’ development programs to allow data-driven decision-making. From candidate nomination through to commercialization and in close partnership with the Primary Focus Divisions, Medical Affairs and Early Development, SRS is accountable for all statistical aspects globally.
Using state-of-the-art methodology and the most innovative approach, SRS generates compelling evidence using clinical trials or real-world data (RWD) to ensure successful and timely regulatory approval, pricing, reimbursement, and patient access.
• This position is an individual contributor role, reporting to an Assoc. Director, Director or Sr Director.
• This position is a hybrid position.
• This position is part of Statistical Programming Cell and Gene Therapy & Biopharma in SRS.

【応募要件 / Qualifications】
Education / experience
• Bachelor’s or master’s in statistics, mathematics, or related field
• 1+ years (3+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry and working with vendors

Competencies (minimum requirements)
• Foundational understanding of pharmaceutical industry leading practices (e.g., regulatory framework, inspection process, HTA guidance, technologies, systems, etc.)
• Foundational understanding of and experience with clinical datasets, statistical methodology, and CSR/submission deliverable
• Experience with pharmaceutical vendors/CROs, management and oversight of Data Science activities
• Foundational understanding of the data science lifecycle and process flow (e.g., ETL, data quality, statistical data analysis, machine learning, data randomization process, etc.)
• Proficient hands-on programming experience with SAS and preferably one or more statistical/data science programming languages (e.g., R, Python). This includes a deep understanding of SAS analytical tools such as SAS/BASE, SAS/STAT and SAS/GRAPH), writing code to manipulate data and analyze a wide array of data sources/types
• Understanding of data standards(CDISC), TLFs, and submission guidelines
• Foundational understanding of common statistical and data quality systems and tools (e.g., Pinnacle21)
• Understanding of study documents such as Protocol, SAP, TLF specs, and data specification
• Shows foundational ability to read, analyze, and communicate large and small amounts of data efficiently; applies experience that can span across statistical modeling, descriptive statistics, and other data analysis techniques
• Foundational skills at understanding and clearly communicating the goals of internal teams and external stakeholders, ensures they meet their goals and expectations; ensures cross-functional collaboration; shows ability to deliver through others
• Foundational skill at Identifying and communicating project goals, timelines, and milestones; identifies project interdependencies and potential constraints
• Proficiently applies consistent, thorough, and accurate execution/review of documents
• Foundational skills at finding and analyzing logical flaws/gaps in plans and processes; Identifies problems and solutions that others might miss; works autonomously and takes initiative

【応募書類 / Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed

【選考プロセス / Selection details】
書類選考 → 1次面接 → 最終面接(複数回)
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → Final interview
*Please be advised that there might be a change in the process.

【勤務地 / Location】
(雇入れ直後 / Immediately after hiring)
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo

(変更の範囲 / Scope of change)
会社の定める事業場および自宅
Workplace determined by the company, or your houce

【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50,000~100,000円支給
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)

【昇給 / Salary Raise】
有り

【賞与 / Bonus】
有り

【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)、8:45~16:00(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
8:45~17:45(Mon~Thu)、8:45~16:00(Fri)
Discretionary Work System

【休日 / Holidays】
完全週休2日制(土曜・日曜)、祝日、5月1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

【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.

"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."

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Refer code: 1250106. Astellas Pharma - その前日 - 2024-03-21 17:15

Astellas Pharma

Tokyo, Nihonbashi

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