Associate Principal Scientist (Epidemiology)

Astrix Inc.; North Wales (Montgomery County); Hybrid; USD 125,000 - 150,000; Full time

Job summary

An innovative global pharmaceutical powerhouse is seeking an Associate Principal Scientist to enhance their dynamic team. This role focuses on coordinating COA/PRO strategic plans and ensuring alignment with clinical trial goals. You will be at the forefront of developing and validating instruments crucial for clinical studies, facilitating the integration of COA/PRO methodologies, and producing scientific communications. Join a trailblazing company committed to advancing health solutions and making a significant impact in the pharmaceutical industry. If you have a passion for research and a desire to contribute to life-saving innovations, this opportunity is perfect for you.

Qualifications

• PhD (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in relevant fields.
• Experience with COA/PRO methodologies and regulatory requirements.

Responsibilities

• Coordinate global COA/PRO strategic plans for clinical teams.
• Support development and validation of COA/PRO instruments.
• Conduct literature searches to support endpoint strategies.

Skills

Project Management

Communication Skills

Data Analysis

Health Services Research

Knowledge of COA/PRO methodologies

Education

PhD in Health Services Research or related field

MS in Health Services Research or related field

BS in Health Services Research or related field

Job description

Clinical

Our client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an Associate Principal Scientist to join their dynamic team.

Type: Contract
Location: North Wales, PA (Hybrid)
Pay: $58.67 - $71.43/hr

Responsibilities:

1. Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals.
2. Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies.
3. Provide guidance on implementing COA/PRO instruments into studies.
4. Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.
5. Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies.
6. Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies.
7. Conduct literature searches to support COA/PRO endpoint strategies.
8. Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.).
9. Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.

Qualifications:

1. PhD (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in Health Services Research, Statistics, Psychometrics, Outcomes Research (or closely related field) with relevant industry work experience in the COA field.
2. Familiar with COA/PRO requirements for regulatory and reimbursement agencies.
3. Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies.
4. Ability to understand and respond to multiple internal and external customers.
5. Strong project management and communication skills.
6. Experience with COA/PRO-related scientific presentations and publications.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!