Sr. Manager, Clinical Data Analytics

Alkermes

About The Position

Develop, test, and deploy Visualization dashboards using Tableau/Spotfire, providing information about data quality and study metrics. Provide ad-hoc programming support to ensure rapid access to clinical study data for data cleaning/validation and Clinical Data review. Create data mappings to organize data as per standards. Develop and maintain data ingestion programs to snowflake database. Responsible for internal programming and ad-hoc requests for clinical programs from database start-up through database lock. Manage programming relationships specific to metrics and dashboards, data cleaning, ad-hoc reporting, data review, data surveillance, and data mining. Oversee programming specifications, templates, and documentation in accordance with ICH/GCP guidelines and current regulatory requirements. Ensure the visualizations are validated and follow SDLC standards. Develop database views with CDISC standards. Develop and maintain eCRF standards across the department that can be utilized for eCRF development as well as data visualizations. Work closely with clinical data managers, safety and clinical teams to collect requirements for developing KPIs and KRIs for the study. Develop python scripts for identifying data anomalies within data and also to reconcile against external lab data.

Requirements

Bachelor’s degree in Data Analytics, Data Science, or a related field and six years of experience in data analytics.
Six years using data visualization tools such as Tableau, Spotfire, or Power BI.
Five years using programming tools such as Python, R, SQL or SAS.
Four years developing POC and MVP with AGILE development principles.
Three years working in cross-functional, multicultural and international clinical trial teams.
Three years working with GCP/ICH standards, 21 CFR Part 11.
Two years SDLC and GCP validation.
One year CDISC SDTM standards.
One year working with databases and data modeling.

Responsibilities

Develop, test, and deploy Visualization dashboards using Tableau/Spotfire, providing information about data quality and study metrics.
Provide ad-hoc programming support to ensure rapid access to clinical study data for data cleaning/validation and Clinical Data review.
Create data mappings to organize data as per standards.
Develop and maintain data ingestion programs to snowflake database.
Responsible for internal programming and ad-hoc requests for clinical programs from database start-up through database lock.
Manage programming relationships specific to metrics and dashboards, data cleaning, ad-hoc reporting, data review, data surveillance, and data mining.
Oversee programming specifications, templates, and documentation in accordance with ICH/GCP guidelines and current regulatory requirements.
Ensure the visualizations are validated and follow SDLC standards.
Develop database views with CDISC standards.
Develop and maintain eCRF standards across the department that can be utilized for eCRF development as well as data visualizations.
Work closely with clinical data managers, safety and clinical teams to collect requirements for developing KPIs and KRIs for the study.
Develop python scripts for identifying data anomalies within data and also to reconcile against external lab data.