Job Description

Location: Preference for candidates local to Princeton, NJ or Rockville, MD . Remote considered for the right candidate (must work East Coast business hours).
Position Summary
We are seeking a Data Scientist Consultant to support analytical and stability activities for developmental, clinical, and commercial pharmaceutical products. This role will focus on ensuring compliance with GxP requirements, managing analytical data, and providing statistical insights to support regulatory submissions and business decision-making.
Key Responsibilities
Review analytical data (including raw data) for accuracy and compliance with internal and GxP requirements.
Initiate and monitor stability studies for developmental, clinical, and commercial pharmaceutical products tested by contract labs.
Review, enter, and maintain stability data for pharmaceutical products.
Create and manage studies in LIMS for multiple projects.
Enter or review sample test result data in LIMS.
Assist with technical investigations; enter deviations and investigations into Trackwise.
Maintain and manage analytical testing documentation (protocols, reports, data) in compliance with GDP and data integrity standards.
Prepare stability reports and summaries for INDs, NDAs, and regulatory submissions, ensuring accuracy and adherence to regulatory requirements.
Apply descriptive statistics to organize and summarize data.
Use statistical analysis techniques to identify patterns and trends based on project needs.
Generate graphs, profiles, and reports of testing/stability data and statistical analysis.
Collaborate with project teams to support informed business decisions through data-driven insights.
Qualifications
Required:
Bachelor’s degree in Chemistry or related science.
5+ years of experience in a GxP environment focused on analytical laboratory testing of pharmaceuticals.
Familiarity with GMP environments and analytical laboratory testing methods (HPLC, Dissolution, etc.).
Strong communication and interpersonal skills; ability to collaborate with internal and external stakeholders.
Proficiency in MS Office (Excel, Word, PowerPoint).
Demonstrated experience with data review.
Excellent oral and written communication skills.
Nice To Have
Experience with electronic document management systems (Veeva, CARA, etc.).
Experience with investigation software (Trackwise preferred).
Experience with LIMS (Laboratory Information Management Systems).
Strong planning, organizational, and coordination skills.

Job Tags

Contract work, Local area, Remote work,

Similar Jobs

Sport Clips

Hair Stylist/Barber - Competitive pay Job at Sport Clips

Now hiring for Hair Stylist and Barber positions. Join our Sport Clips Salon in Vadnais Heights, Minnesota and make $25 - $30+ an hour! Our Salon offers industry leading mentorship, training and compensation: hourly + commission + tips + yearly bonus! We take pride in...

KIDZ MEDICAL SERVICE.

Credentialing Specialist Job at KIDZ MEDICAL SERVICE.

...Job Description Job Description Seeking a full-time in-person credentialing specialist to join our large pediatric multi-specialty practice. Flexible work hours available. SUMMARY: Coordinates all functions related to the credentialing and recredentialing of health...

One Medical

Family Nurse Practitioner or Physician Assistant Job at One Medical

...certification\n ~ In the past 5 years, practiced as an Advanced Practitioner for at least: \n \n ~2 years in an outpatient primary care... ...Free One Medical memberships for yourself, your friends and family \n Employee Assistance Program - Free confidential services...

North Atlantic Service

CDL Fuel Delivery Driver - $30-$34/hr! - Home Daily Job at North Atlantic Service

...CDL Fuel Delivery Driver: Atlantic Fuels is seeking an experienced CDL Driver . We are an expanding fuel delivery company based in Rye, NH with a loyal customer base in Seacoast New Hampshire, and southern Maine. The CDL Fuel Delivery Driver is responsible for...

Senior Helpers - Northside Chicago

Live in Caregiver Job at Senior Helpers - Northside Chicago

...Job Description Job Description LIVE-IN CAREGIVER Caregiver will have private bedroom Senior Helpers is proud to be the first and only national in-home care provider to receive certification as a Great Place to Work. Our caregivers and staff are treated with...

Data Scientist Consultant Job at Advanced Clinical, Rockville, MD

b0lpN2dpcWVZaU8rR1dYQWx4c1ZmS3hRa0E9PQ==