Principal Clinical Data Scientist

• Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies
• BA / BS in the biological sciences, computer sciences, mathematics, or data sciences and / or related disciplines in the natural science / health care space
• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• In-depth knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows
• Sound knowledge of analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Expertise in protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis / data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment

Responsibilities

• Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions;

escalates issues which potentially impact patient safety and study analysis

• Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables
• Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies
• Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements
• Design and drives the development of analytical tools, utilizes analytical platform / dashboard to detect potentially unreliable data that may impact the validity of the trial results
• Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools / metrics
• Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Perform metric collection and data analysis to support continuous process improvement
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains project plans, specifications, and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Actively promote new clinical data science business opportunities aligned with sponsor strategies
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science systems and processes through regular training
• Performs other work-related duties as assigned
• We are passionate about developing our people, through career development and progression; supportive and engaged line management;

technical and therapeutic area training; peer recognition and total rewards program

Qualifications

• Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies
• BA / BS in the biological sciences, computer sciences, mathematics, or data sciences and / or related disciplines in the natural science / health care space
• In lieu of degree, equivalent relevant work experience
• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• In-depth knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows
• Sound knowledge of analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Expertise in protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis / data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment

Responsibilities

• Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions;

escalates issues which potentially impact patient safety and study analysis

• Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables
• Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies
• Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements
• Design and drives the development of analytical tools, utilizes analytical platform / dashboard to detect potentially unreliable data that may impact the validity of the trial results
• Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools / metrics
• Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Perform metric collection and data analysis to support continuous process improvement
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains project plans, specifications, and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Actively promote new clinical data science business opportunities aligned with sponsor strategies
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science systems and processes through regular training
• Performs other work-related duties as assigned

Benefits

We are passionate about developing our people, through career development and progression; supportive and engaged line management;

technical and therapeutic area training; peer recognition and total rewards program

Description

Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now.

Principal Clinical Data Scientist...

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management;

technical and therapeutic area training; peer recognition and total rewards program.

• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities

• Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups.
• Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
• Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
• Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions;

escalates issues which potentially impact patient safety and study analysis

• Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables
• Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies.

Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.

• Design and drives the development of analytical tools, utilizes analytical platform / dashboard to detect potentially unreliable data that may impact the validity of the trial results.
• Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies
• Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues
• Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools / metrics
• Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
• Perform metric collection and data analysis to support continuous process improvement
• Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
• Plans, manages, and requests Clinical Data Science resources for assigned projects
• Coordinates the work of the assigned Clinical Data Science team
• Develops and maintains project plans, specifications, and documentation in line with SOP requirements
• Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
• Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
• Actively promote new clinical data science business opportunities aligned with sponsor strategies.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
• Trains and mentors new or junior team members
• Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend / represent the company at professional meetings / conferences
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)

Qualifications

What we’re looking for

BA / BS in the biological sciences, computer sciences, mathematics, or data sciences and / or related disciplines in the natural science / health care space.

MS degree is preferred. In lieu of degree, equivalent relevant work experience

• Clinical Data Science experience or an equivalent combination of education and experience
• Experience in Clinical Data Science practices and relational database management software systems
• In-depth knowledge of the drug development process and its impact on data quality, in particular risk-based approach, biometrics procedures, workflows.
• Sound knowledge of analytic modeling methods such as regression, classification and clustering
• Strong project management skills and knowledge of project management methodologies
• Strong analytical skills and knowledge of Artificial intelligence / machine learning methodologies preferred
• Demonstrated staff leadership skills
• Knowledge of ALCOA++ data quality principles
• Expertise in protocol interpretation, data collection and data cleaning specification development
• Experienced with data analysis / data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS
• Knowledge of medical terminology, clinical data, and ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
• Effective oral and written communication and presentation skills
• Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
• Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team
• Ability to make effective decisions and manage multiple priorities in a highly dynamic environment

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Learn more about Syneos Health.

Additional Information :

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job

Company information

Syneos Health (Nasdaq : SYNH) is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics.

Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.

Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.

Company Specialties :

Clinical Trials and Biopharmaceutical Product Lifecycle Management

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