Lead Report Developer - Hybrid

Job Description

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.

Education: 

• B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.

Required Experience and Skills:

• 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

clinicaltrialjobs

EligibleforERP

#GDMS

Required Skills:

Adaptability, Clinical Data Management, Clinical Research, Communication, Customer Experience Management, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Leadership, Medical Terminology, Project Coordination, Team Management, Teamwork, Vendor Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

04/18/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.