Manager, Clinical Data Scientist, Clinical Data Sciences

$93,500 - $155,900/Yr

Pfizer - New York, NY

Full-time - Mid Level

New York, NY

Chemical Manufacturing

About the position

As part of the Clinical Data Sciences (CDS) group within the Global Biometrics and Data Management (GBDM) organization at Pfizer, the Clinical Data Scientist (CDS) plays a crucial role in ensuring the timely and high-quality delivery of data management services that support the Pfizer portfolio. The CDS is responsible for developing asset-level information strategies that optimize the use and reuse of both internal and external data, which is essential for advancing research, development, and commercialization efforts, particularly in the realm of precision medicine. This position involves designing, developing, and maintaining key data management deliverables that are vital for collecting, reviewing, monitoring, and ensuring the integrity of clinical data. The CDS applies established standards, manages data review processes, and is accountable for the quality of study data set releases, ensuring consistency in asset and submission data. In this role, the Clinical Data Scientist will serve as the Trial Lead for one or more clinical trials, taking on full responsibility for all CDS activities. This includes the selection and application of data acquisition standards, the creation of Data Management Plans, and the identification of quality risk indicators. The CDS will act as a technical resource for study teams, providing guidance on data management and risk-based monitoring standards, tools, data provisioning, and reporting. Collaboration is key, as the CDS will partner with Research and Business Units, external data management service providers, and internal CDS staff to ensure high-quality data management across all assigned studies. The role requires proactive management of quality and efficiency to meet timelines and milestones, ensuring scientific and operational excellence in alignment with strategic imperatives and in collaboration with cross-functional study teams. The Clinical Data Scientist will also ensure that all work conducted by or on behalf of CDS adheres to applicable Standard Operating Procedures (SOPs) and working practices. Participation in the design and implementation of quality databases, including documentation and testing of clinical data collection tools, is essential. The CDS will ensure that all required study-specific documents are of high quality and filed contemporaneously in the Trial Master File (TMF). Operational excellence is a priority, with a focus on applying standards, proactive data review, data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.

Responsibilities

• Serve as Clinical Data Scientist and Trial Lead for one or more clinical trials, assuming responsibility for all CDS activities.
• Select and apply data acquisition standards, create Data Management Plans, and identify quality risk indicators.
• Act as a technical resource to study teams for data management and risk-based monitoring standards, tools, data provisioning, and reporting.
• Collaborate with Research/Business Units, external data management service providers, and internal CDS staff to deliver high-quality data management for all assigned studies.
• Proactively drive quality and efficiency to meet timelines and milestones for data management, ensuring scientific and operational excellence.
• Ensure compliance with applicable SOPs and working practices in all CDS activities.
• Participate in the design and implementation of quality database systems, including documentation and testing of clinical data collection tools.
• Ensure high-quality study-specific CDS documents are filed contemporaneously in the Trial Master File (TMF).
• Maintain operational excellence in collaboration with partners for data acquisition, proactive data review, data integrity monitoring, and database release.

Requirements

• Demonstrated successful experience in all relevant clinical data management activities in a BioPharmaceutical or CRO setting.
• Working knowledge of all phases of clinical trials and ability to assess and determine study requirements from protocol review.
• Strong project and risk management skills; CRO and vendor oversight experience preferred.
• Minimum 5 years of data management experience required.
• Working knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.
• Proficient experience using commercial clinical data management systems and/or EDC products (Oracle RDC / Inform preferred).
• Experience using relational databases (e.g., MS SQL Server, MS Access, or Oracle) and data visualization tools (e.g., Spotfire, jReview).
• Familiarity with MedDRA/WHO-Drug is preferred.
• Bachelor's degree required; degree in a scientific field preferred.

Nice-to-haves

• Master's degree preferred.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage
• Participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary
• Eligibility to participate in share-based long-term incentive programs
• Relocation assistance may be available based on business needs and/or eligibility.