Senior Lead Clinical Data Science Programmer

Overview

The role involves being a Senior Lead clinical data science programmer in the Clinical Data Management area, focusing on enhancing data review and cleaning processes with innovative reports. It entails creating and implementing study-specific data validation procedures and reports, managing the connection to varied data sources, and ensuring efficient scheduling, monitoring, and maintenance on the Clinical Data platform. The role requires detailing key handling requirements for scalable data management methods, and deriving study-specific monitoring and validation reports based on clinical protocols and amendments. Ultimately, this position aims to advance clinical data management and informatics by improving data integrity, efficiency, and capacity for expansion.

Responsibilities

Engage closely with Global Development business units such as BDM, Safety, Precision Medicine, Pharmacometrics, Digital Health to deeply understand data quality, monitoring and validation needs and transform these insights into detailed business requirements for clinical data products.

Act as the primary point of accountability, responsibility, and expertise in interpreting Clinical Data business needs, meticulously translating and documenting these into comprehensive business specifications at the segment, modality, and company-wide levels.

Demonstrates a business understanding of study specific data to identify and assist in successful application of consistent data management processes and documentation across assigned programs, ensuring consistency across data quality plans.

Thoroughly document the clinical product development process, including data sources, methodologies, algorithms, and underlying assumptions, to guarantee transparency, reproducibility, and auditability of clinical data products.

Craft study-specific Data Quality specifications and define key Clinical data metrics to uphold the highest data quality and integrity standards across study lifecycles.

Prepare study-level reports within the Clinical Data Platform to support stakeholder activities and ensure the effective use of clinical study data.

Query small to large clinical data sets, manage data ingestion and delivery specifications, and data modeling requirements. Analyze and evaluate clinical data, recognize inconsistencies, and initiate the resolution of data issues.

Design clear, concise requirements for clinical reports and dashboards, establishing relevant metrics to convey data-driven insights. Present findings in a compelling manner, customized for key clinical business functions such as Clinical Data Management, Pharmacometrics, Precision Medicine, etc.

Work towards preparing Common Data Model mapping and transformations to ensure data is usable in the analytical layer and comply with the Governance Committee strategy.

Have hands-on experience with various clinical datasets such as EDC and non-CRF data combined with strong analytical abilities capable of managing diverse, large, and complex datasets, which ranges from fundamental research collections to detailed clinical information.

Possess a deep understanding of modern data analytic frameworks and technology, which includes expertise in Big Data structures, Lakehouse architectures, as well as contemporary techniques for data collection and amalgamation.

Have a full understanding of clinical trials.

Have a passion for championing and implementing clinical data.

Should have practical experience with ETL processes, programming languages such as SQL, Python, R, and familiarity with the AWS cloud infrastructure, including S3, Data Lake, along with analytics realms.

Have strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail.

Possess excellent communication and project management skills.

Qualifications

Have a bachelor’s degree in computer science, Data Science, Statistics, or a similar area is required. Candidate should have substantial experience, ideally over 7 years, specifically within clinical data analysis and preferably within the BioPharma sector.

Important Information for Applicants:

• This role does not offer remote work and is not open to freshers.

• Please review the job description carefully before applying.