Description
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 qualityEnsures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysisWorks 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 analysisCoordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverablesDevelops 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 studiesPerforms analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issuesMonitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools / metricsEnsures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulationsPerform metric collection and data analysis to support continuous process improvementReview, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change orderPlans, manages, and requests Clinical Data Science resources for assigned projectsCoordinates the work of the assigned Clinical Data Science teamDevelops and maintains project plans, specifications, and documentation in line with SOP requirementsMaintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary filesParticipates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilitiesPrepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilitiesActively 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 responsibilitiesTrains and mentors new or junior team membersMaintains proficiency in Clinical Data Science systems and processes through regular training. May attend / represent the company at professional meetings / conferencesPerforms 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 experienceClinical Data Science experience or an equivalent combination of education and experienceExperience in Clinical Data Science practices and relational database management software systemsIn-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 clusteringStrong project management skills and knowledge of project management methodologiesStrong analytical skills and knowledge of Artificial intelligence / machine learning methodologies preferredDemonstrated staff leadership skillsKnowledge of ALCOA++ data quality principlesExpertise in protocol interpretation, data collection and data cleaning specification developmentExperienced with data analysis / data review and visualization tool sets including but not limited to Python, R, Spotfire, SASKnowledge of medical terminology, clinical data, and ICH / GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data SciencesProficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applicationsEffective oral and written communication and presentation skillsGood organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detailAbility to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary teamAbility to make effective decisions and manage multiple priorities in a highly dynamic environmentAt Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
The annual base salary for this position ranges from $109,711 to $175,700. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
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.
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