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新着求人 統計解析(BO)
募集職種 データサイエンス部プログラミングジャパン シニアスタッフorスタッフ
統計解析関連の求人はこちらから
勤務地 東京
会社概要 非公開
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求人要件 Basic purpose of the job

Supports the clinical research development process by providing statistical programming for new substances, indications or marketing claims. Is able to function as a Project Programmer (PPROG) or as the Trial Programmer (TPROG) focusing on complex trials that represent new challenges and for which project and therapeutical knowledge is not given, such as mega trials in new indications. Is also able to supervise CROs working within the statistical programming area on trial level.
Works directly with the trial and project statistician and proactively with the Clinical Trial and Project teams - providing programming support. Implements and supports standards and a harmonized approach to programming.

As a TPROG, utilize SOPs and guidelines, the TPROG and trial and project documentation to support the programming requirements of the Medical Quality Review Plan (MQRP), the Trial Statistical Analyses Plan (TSAP) and other supporting reports for trials of Phase I - IV. Gain specific knowledge about the clinical data collected for the trial. Attend trial meetings as necessary (e.g. Trial Preparation Meeting, Medical Quality Review Meeting, Blinded Report Planning Meetings). Communicate with other trial team members as needed. Keep management abreast of critical process issues, resource shortages and changes in timelines. Keep tracking systems current.

As a PPROG, provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation activities to ensure the quality of the submission. Keep abreast of international data standards (e.g. CDISC) and supply programming support to the project team to accomplish this requirement from the regulatory authorities.

Review and provide feedback to the trial or project statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs. Author or co-author the Analysis Data Set (ADS) specification with the statistician. Challenge the Technical TSAP and PSAP to ensure the most standardised and efficient processes can be used for its implementation. Ensure programming issues are resolved and specifications are kept updated in the SAP. Communicate and collaborate with the CRO programmer when any part of the programming is outsourced.

Transform specifications in the Project and Trial Statistical Analyses Plans (P/TSAP) into fully documented and tested programs supporting both safety and efficacy displays and Analyses Data Sets (ADS) required for the Clinical Trial Report. This includes: standard displays that require complex data building programming prior to the call of a standard macro; moderate to complex safety displays that cannot be produced by the use of a standard macro; efficacy displays that require applied statistics knowledge in order to produce well documented tested efficacy programs; and the creation of Analyses Data Sets (ADS) that may require the application of statistical methods; implementation of tables as specified in the MQR plan. Reviews the TLFs across the displays for consistency prior to review by the statistician.

Help maintain libraries of fully documented and validated programs, macros and procedures which can be reused by other programmers to aid the department's overall efficiency.
The PPROG develops a project programming strategy with the PSTAT and PDM, involving the trial teams as well. Define critical steps and decisions to be made to enable timely reportingin phase III on trial and project level. Implement project programs as much as possible and enable usage across trials.

Communicate and collaborate with the CRO programmer when part of the trial programming or double programming is outsourced, providing any necessary oversight.

Represents the Statistical Programming function on multi disciplinary, international working groups, with the ability to lead international working groups.

Regulatory and / or Organisational Requirements
Supports clinical development within in harmony with company standards, GCP and ICH quality standards and regulations in the area of statistical programming.

Job Complexity:
・International exposure in daily business (>50% of international business/customers/staff) > 1.5 years;

Interfaces:
・Clinical Trial and Project Team functions
・Global BCA colleagues
・PK
・CROs

Job Impact:
Biostatistics & Data Sciences (BDS) transforms unstructured data into information that forms the basis of decision making and knowledge base for the company - without Biostatistics & Data Sciences (BDS) no drug approvals. Biostatistics & Data Sciences (BDS) guarantees a scientific and rational approach to clinical trials and therefore clinical data. In addition to Medicine (with the functions of Clinical Operations, Translational Medicine, Clinical Development, Medical Affairs and Drug Regulatory Affairs(DRA)), Biostatistics & Data Sciences (BDS) also supports Research & Development(R&D), Epidemiology, Pharmacovigilance, Operations, Marketing, Vetmedica, Consumer Health Care(CHC), and Biosimilars in statistical planning, management and analyses of their data.
必要要件 ・学士号または修士号(MBA、MScなど)
・コンピュータサイエンスや数学などの技術分野の理学士号と、5年以上のプログラミング経験、または技術分野の理学修士号と3年以上のプログラミング経験。
・臨床試験プログラミングで使用されるSASプログラミング言語のすべての側面に関する熟練した実務知識。
・臨床試験の分析と報告をサポートする統計的概念の実用的な知識
・データベース構造とセットアップに関する知識
・基本的な医学用語の知識
・ Good written and oral communications skills in both English and Mandarin languages
年収 700万円 〜 1200万円
募集背景 非公開
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