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Position Summary

Manager of Statistical programming provides comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.

This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data.

Manager of Statistical Programming develops collaborative relationships and work effectively within Global Biometrics & Data Sciences, with external vendors and members of cross-functional development teams.

Manager of Statistical Programming also needs to do hands on work on creating TLFs and CDISC related tasks.

Direct Reports
None. Possible contractors/leased workers.

Vendor Oversight
Yes

Key Business Partners
Internal/extrernal stakeholders, project team members, vendors

Key Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
• Support the electronic submission preparation and review
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
• Identifies opportunities for increased efficiency and consistency within BDSJ and our interactions with strategic vendors
• Independently leads and / or performs programming assignments across multiple projects with mínimal supervision
• Support improvement initiatives
  Skills, knowledge, and experience

Minimum Requirements:

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 4 years programming experience in industry.
• Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs
• Have indepth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, esubmission.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.
• Strong written and oral communication skills in Japanese and English

Preferred Requirments:

• Minimum of 4 years clinical / statistical programming experience within pharmaceutical clinical development
• Supporting regulatory filings
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirementsExperience in other software packages (e.g. R)

ポジション概要
統計プログラミングのマネージャーは、ブリストルマイヤーズスクイブ(BMS)製品の開発、規制当局の承認、および市場での受け入れをサポートするために、臨床プロジェクトチームに包括的なプログラミングの専門知識を提供します。このポジションは主に、臨床データを統合、分析、および報告するための技術ソリューションの設計、開発、および実装を担当しています。統計プログラミングのマネージャーは、外部ベンダーや部門横断的な開発チームのメンバーと、グローバルバイオメトリクス&データサイエンス内で協力関係を築き、効果的に作業します。統計プログラミングのマネージャーは、TLFおよびCDISC関連のタスクの作成に関する実践的な作業も行う必要があります。


Direct Reports:
なし(ただしcon

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