【Non-line Manager】

Basic purpose of the job

Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to projects like actual clinical trial data, clinical registries and real-world data bases. In particular this includes the provision of analytics tools, outputs and inference as necessary for the specific use case.
May act as a BDS product owner up to substance/asset level.
Represent BDS at a substance/asset level regarding data science related aspects.

Accountabilities

・Lead and oversee designing, transforming, analyzing and reporting complex studies/projects such as complex phase I-IV clinical trials or projects with established BI experience and supporting complex international projects. Lead and oversee designing, transforming, analyzing and reporting of other data from the clinical drug life cycle process like registries and real-world data bases with respect to a specific use case or project/asset.

Related performance indicators

Quality transforming, analyzing and reporting deliverable per process, with timeline adherence. 
Feedback from development team colleagues within and outside BDS, related POs and capability managers.

・Keep abreast of data science within and outside BI. Turn derived insights into new data science approaches relevant for discovery, clinical development, registration, manufacturing or marketing of drugs.

Related performance indicators

Quality of new solutions and innovative processes/ tools. Feedback from team colleagues within and outside of BDS, related POs and capability managers. 

・Present compelling validated stories regarding complex data science aspects to BDS colleagues and other professionals within and outside of BI.

Related performance indicators

Quality and frequency of stories presenting. Feedback from audience regarding their understanding.

・Ensure data transformation and analysis specifications to ensure completeness, correctness and adherence to department guidelines and SOPs as well as to applicable GxP requirements.

Related performance indicators

Quality and regulatory acceptability of data transformation and analysis specifications.

・Guide and/or lead other colleagues, internal and external customer and external providers on data science related tasks.

Related performance indicators

Feedback & satisfaction from colleagues guided. Increased knowledge sharing in the CDS Community of Practice.

・Participate in cross-functional BI internal working-groups or lead cross-functional One Human Pharma internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.

Related performance indicators

Frequency and quality of participation/leadership. Impact of external WG results on business. Feedback from GPO/PO.

・If applicable, supports the clinical drug life cycle process as a BDS Product Owner up to the level of substance/assets.

Related performance indicators

Quality of leadership and deliverable per product, with timeline adherence. Feedback from team colleagues within and outside of BDS, related POs and capability managers. 

・Ensures cross-functional and team-based working within BDS and with other units at BI. Fulfils tasks of other functions as needed and possible. Contributes to cross-functional- and team-based thinking.
Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.

Related performance indicators

Quality and frequency of cross-functional tasks being performed and/or cross-functional collaborations.
Quality and frequency of innovative digital approaches. 
Feedback from team colleagues within and outside BDS, related POs and capability managers.

Regulatory and / or Organisational Requirements

Know, understand, and implement 
(i) international regulations and guidelines for good clinical and statistical practice from all ICH regions, 
(ii) the various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and 
(iii) BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan), and, if necessary, 
(iv) other internal or external regulations such as good laboratory practice or good manufacturing practice.

Job Complexity

Solves complex, defined problems with strategical impact within clinical drug life cycle process, taking into account needs and requirements of other units and departments.

Interfaces

Interacts with various other functions and roles within and outside of BDS leading and/or having strategical impact regarding substance level. This includes colleagues from GCO, GPV, Therapeutic Areas, TMCP, GRA, Research, Development and Pharma Supply. Represents BI for critical regulatory issues and requests around planning, analyses and data transformation regarding the project/asset.

Job Expertise

- Understanding and applying key of principles of data science.
- Demonstrated broad knowledge in planning, transforming, analysing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources related to the clinical drug life cycle process.
- Broad knowledge and advanced experience in software languages relevant for business needs.
- Broad knowledge and advanced experience in understanding of clinical drug life cycle process, e.g. clinical trial development process, is required.
-Advanced project lead experience required.
PhD: 3 years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; 
MSc: 6 years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; 
Bachelor: minimum 7 years of data science experience.
- Working experience might be partially compensated by broad and deep topic-specific knowledge.

Job Impact

Responsible for all aspects of analysing data from clinical drug life cycle process at BI and presenting the results to our internal and external customers adapted to the needs of the customer. Independent decision making is needed as outlined in the accountabilities.

Minimum Education/Degree Requirements

Bachelor of Science (BSc), Master of Science (MSc) or Doctoral Degree (PhD) in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc).

Required Capabilities (Skills, Experience, Competencies)

- Thorough knowledge of statistical methodology, design of experiments such as clinical trials, basic terminology of the supported area/asset and on processing information such as clinical trial information.
- In-depth understanding of advanced statistical concepts related to Data Science.
- Language skills: English: fluent (Read/Write/Speak).
- Advanced working knowledge of broad variety of aspects of relevant software languages.
- Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
- Ability to lead and facilitate meetings.
- Ability to develop and deliver training related to data science topics.
- Evidence of strong teamwork, also in global and remote context.
- Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).
- Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.

【Staff】

Basic purpose of the job

Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to projects like actual clinical trial data, clinical registries and real-world data bases. In particular this includes the provision of analytics tools, outputs and inference as necessary for the specific use case.
May act as a BDS product owner on project/asset level.
Represent BDS at a project/asset level regarding data science related aspects.

Accountabilities 

・Accountable for transforming, analyzing and reporting studies/projects such as phase I-IV clinical trials and supports complex studies/projects such as complex phase I-IV clinical trials or projects with established BI experience. Accountable for transforming, analyzing and reporting of other data from the clinical drug life cycle process like registries and real-world data bases with respect to a specific use case or project/asset.

Related performance indicators

Quality transforming, analyzing and reporting deliverable per process, with timeline adherence. 
Feedback from development team colleagues within and outside BDS, related POs and capability managers.

・Keep abreast of data science and in particular new transformation and analysing solutions and innovative processes/tools within and outside BI.

Related performance indicators

Quality of new transformation and analysing solutions and innovative processes/tools. Feedback from team colleagues within and outside of BDS, related POs and capability managers. 

・Present compelling validated stories regarding data science aspects to BDS colleagues and colleagues within and outside of BI with basic knowledge in data science.

Related performance indicators

Quality and frequency of stories presenting. Feedback from audience regarding their understanding.

・Ensure data transformation and analysis specifications to ensure completeness, correctness and adherence to department guidelines and SOPs as well as to applicable GxP requirements.

Related performance indicators

Quality and regulatory acceptability of data transformation and analysis specifications.

・Support other colleagues, internal and external customer and external providers on data science related tasks.

Related performance indicators

Feedback & satisfaction from colleagues supported. Increased knowledge sharing in the CDS Community of Practice.

・Participate in cross-functional One Human Pharma internal working-groups or lead cross-functional BDS internal working-groups and drive/plan relevant data science aspects.

Related performance indicators

Frequency and quality of participation/leadership. Impact of WG results on business. Feedback from GPO/PO.

・If applicable, supports the clinical drug life cycle process as a BDS Product Owner on the level of projects/assets.

Related performance indicators

Quality of leadership and deliverable per product, with timeline adherence. Feedback from team colleagues within and outside of BDS, related POs and capability managers. 

・Ensures cross-functional and team-based working within BDS and with neighbouring units at BI. Fulfils tasks of other functions as needed and possible. Contributes to cross-functional- and team-based thinking.

Related performance indicators

Quality and frequency of cross-functional tasks being performed and/or cross-functional collaborations. Feedback from team colleagues within and outside BDS, related POs and capability managers.

Regulatory and / or Organisational Requirements

Know, understand, and implement 
(i) international regulations and guidelines for good clinical and statistical practice from all ICH regions, 
(ii) the various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and 
(iii) BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan), and, if necessary, 
(iv) other internal or external regulations such as good laboratory practice or good manufacturing practice.

Job Complexity

Solves complex, defined problems with operational/limited strategical impact within clinical drug life cycle process, taking into account needs and requirements of other units and departments.

Interfaces

Interacts with various other functions and roles within and outside of BDS contributing to and/or having operational impact regarding substance level. This includes colleagues from GCO, GPV, Therapeutic Areas, TMCP, GRA, Research, Development and Pharma Supply. Represents BI for regulatory issues and requests around planning, analyses and data transformation regarding the trial/project/asset.

Job Expertise

- Understanding and applying key of principles of data science.
- Demonstrated advanced knowledge in planning, transforming, analysing, interpreting, and reporting data in clinical trials, across clinical trials or data from other sources related to the clinical drug life cycle process.
- Advanced experience in software languages relevant for business needs.
- Advanced experience in understanding of clinical drug life cycle process, e.g. clinical trial development process, is required.
- Project lead experience required.
PhD: None; 
MSc: 3 years within the pharmaceutical industry, CROs, regulatory authorities or academic institutions; 
Bachelor: minimum 5 years of data science experience. 
- Working experience might be partially compensated by broad and deep topic-specific knowledge.

Job Impact

Responsible for all aspects of analysing data from clinical drug life cycle process at BI and presenting the results to our internal and external customers adapted to the needs of the customer. Independent decision making is needed as outlined in the accountabilities.

Minimum Education/Degree Requirements

Bachelor of Science (BSc) or Master of Science (MSc) in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc).

Required Capabilities (Skills, Experience, Competencies)

- Sound knowledge of statistical methodology, design of experiments such as clinical trials, basic terminology of the supported area/asset and on processing information such as clinical trial information.
- Understanding of advanced statistical concepts related to Data Science.
- Language skills: English: fluent (Read/Write/Speak).
- Proficient in the use of relevant software languages.
- Mindful of local, global, internal and external cultures to ensure that messages are received positively and effectively.
- Ability to lead and facilitate meetings.
- Evidence of strong teamwork, also in global and remote context.
- Good interpersonal skills with the ability to interact effectively with people, internally and externally (e.g. CROs, experts, management).
- Ability to pro-actively identify issues and solutions and to interact with internal and external bodies on routine data science issues.

Recruiter : Tomatsu