Lead Report Developer - Hybrid

MSD•Rahway, NJ

6d•$117,000 - $184,200•Hybrid

About The Position

Primary activities include, but are not limited to: Assumes the responsibilities for all clinical programing (including reporting and analytics), for standardization, data cleaning and verification including studies and the external data captured in support of the clinical studies. Coordinates and participates in the following activities: Oversees and coordinates data reporting activities for multiple clinical programs. Interfaces with leadership to assure consistency of technical and process strategies. Acts as a technical resource to other members of the group along with understanding of Protocol. Plans appropriately to ensure adherence to timelines. Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables. Leading data analytics efforts including collection, dataset design, development, and researching AI & machine learning systems, models, and schemes Creates and develops reporting specifications to meet regulatory requirements and data cleaning/review needs to ensure quality and availability of reports in support of data review/cleaning activities. Ensures adherence to clinical database standards, SOPs, and Process Guidelines. Leads and participates in the review of eCRFs, standard and template reports, and scripts to aid in the review of data to ensure a quality database in support of Analysis and Reporting performed by Scientific Programming like creating algorithms and data models to forecast outcomes using multiple tools like Python, R, SQL, Celonis, etc. Trains new hires and participates in the interview process. Provide ongoing training and development to Clinical Programmers on existing and new processes. Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings. Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing mapping support to other departments along with managing Incidents, Standard request and RFC’s. Build tools to automate data collection, normalization, and standardization using various tools clinical data management and automation tools. Assist in project planning, manpower projections and resource allocations across therapy areas. Interface with cross functional teams to assure consistency of technical and process strategies across all therapy areas .

Requirements

B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
5 years of experience in common programming languages (e.g., Python, SQL, PHP, JavaScript, HTML, like Databricks, Python, SAS, etc along with AI related tools.
5 + years of exp in the data cleaning and transformation process, through appropriate tools
Experience working in data visualization tools, such as Power BI, Tableau, others
5 + years of Knowledge of analytics, data science, data modeling techniques and database design.
Solid knowledge of System Development Lifecycle Management / system validation knowledge
Ability to establish and maintain good working relationships with different functional areas.
Strong sense of urgency and customer focus.
Possesses excellent communication skills and interacts effectively with Study Team along with Strong organizational and problem-solving skills.
Desire and ability to learn new processes and technologies
Ability to multi-task, work independently, and good communication skills
Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11

Responsibilities

Assumes the responsibilities for all clinical programing (including reporting and analytics), for standardization, data cleaning and verification including studies and the external data captured in support of the clinical studies.
Oversees and coordinates data reporting activities for multiple clinical programs.
Interfaces with leadership to assure consistency of technical and process strategies.
Acts as a technical resource to other members of the group along with understanding of Protocol.
Plans appropriately to ensure adherence to timelines.
Interface with members of study teams and key stakeholders, to integrate requirements into all deliverables.
Leading data analytics efforts including collection, dataset design, development, and researching AI & machine learning systems, models, and schemes
Creates and develops reporting specifications to meet regulatory requirements and data cleaning/review needs to ensure quality and availability of reports in support of data review/cleaning activities.
Ensures adherence to clinical database standards, SOPs, and Process Guidelines.
Leads and participates in the review of eCRFs, standard and template reports, and scripts to aid in the review of data to ensure a quality database in support of Analysis and Reporting performed by Scientific Programming like creating algorithms and data models to forecast outcomes using multiple tools like Python, R, SQL, Celonis, etc.
Trains new hires and participates in the interview process.
Provide ongoing training and development to Clinical Programmers on existing and new processes.
Helps to develop a customer oriented and can-do attitude in the group and contributes as subject matter expert for trouble-shooting findings.
Leads and participates in extra activities including, but not limited to, task forces, testing of new systems and helps coordinate technical initiatives.
Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group.
Provides ongoing mapping support to other departments along with managing Incidents, Standard request and RFC’s.
Build tools to automate data collection, normalization, and standardization using various tools clinical data management and automation tools.
Assist in project planning, manpower projections and resource allocations across therapy areas.
Interface with cross functional teams to assure consistency of technical and process strategies across all therapy areas