Senior Data Scientist

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

We’re looking for a **Senior Data Scientist** to join our **Clinical Data Sciences** team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you’ll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.

**What you’ll be doing**:

- Interacts with internal and external project team members (including external data source vendors) for multiple projects, as appropriate. Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review and/or documentation of minutes.
- Ability to facilitate clinical database development to properly execute collection, receipt, reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and proper execution of User Acceptance Testing, and coordination, planning and development for external data sources as needed.
- Participates in early study team planning of data risk assessment and continuous evaluation of risks throughout course of study. Ability to offer insight or mitigate risks of data loss.
- Communicate with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines as appropriate. Ensure training of study specific protocol requirements as appropriate. Identify and communicate gaps in training and support training of data reviewers.
- Ability to create, maintain, execute and properly store data related documentation as outlined in department operation procedures and as required by study
- Responsible for functional area eTMF filing and quality control activities or equivalent as per study. Participation in internally and externally managed study audits as required.
- Oversee study budget applicable to functional area. Identify and communicate potential out of scope activities to project team as appropriate. Work with study team to provide needed information for re-scoping when applicable.
- Responsible for proper generation, review and reporting of study metrics and financials as needed
- Execute all tasks as aligned with SOPs, department guidelines and data standards

**What We Are Searching For**:

- Minimum of a Bachelor's Degree, preferably in Science, Engineering, or Math, or RN, RPh, or LPN certification preferred along with a minimum of 5 years of mastery in data management/science/analytics/informatics and at least 2 years leading studies
- Proven expertise in ICH/GCP and/or ISO14155 requirements; knowledge of site and institution specific contract requirements; clinical trials support or pharmaceutical industry experience; working knowledge of medical terminology and experience with clinical research; working knowledge of FDA Guidance Documents and clinical monitoring procedures; working knowledge of data standards and data modeling, statistical principles and analysis considerations.
- Understanding and experience at least one Database Management System (e.g., Medidata Rave, Calyx/DataLabs EDC, Oracle Inform, etc.), working knowledge of IVRS/IRT, CTMS, and other platforms relevant to the role.
- Known for being customer-focused in approach to work and communications with the ability to professionally Interact with site, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills.
- Ability to cultivate and thrive in a positive, results-oriented work environment; collaborative; able to build and coordinate efforts of an effective project team.
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strongly committed.

**Why Choose Premier Research?**
- Premier Research is more than a company - it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
- Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
- Our dedicat