Research Scientist - Epidemiology and Scientific Affairs

Thermo Fisher Scientific • Morrisville, MA

2d • $150,000 - $170,000 • Onsite

About The Position

The Real-World Science, Epidemiology and Scientific Affairs team focuses on generating real-world evidence and supports biopharmaceutical companies throughout the product lifecycle, from early pre-launch planning to launch, and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate real-world evidence to demonstrate and support the value of their products. Through the generation of real-world data via the design, implementation, and analyses of observational/non-interventional studies, we may provide key information such as: Pregnancy safety studies (e.g., pregnancy exposure registries, descriptive pregnancy safety studies) Incidence and prevalence of diseases and co-morbidities, and their risk factors Burden of disease, unmet needs Treatment patterns and drug utilization Healthcare resource utilization Overall safety, incidence of adverse events of special interest Effectiveness and comparative effectiveness data. This position will focus on pregnancy safety studies. The Research Scientist takes the role of independent principal investigator/consultant of projects and is responsible for coordinating all aspects of project delivery, including delegating project management tasks to junior staff. This role will also take scientific responsibility for project completion, strategic consultation, and for use of the best methods to address research needs. This position will focus primarily on implementing pregnancy safety studies.

Requirements

• PhD in epidemiology or a closely related field, or MSc with at least 5-7 years of relevant experience.
• Minimum 5+ years of consulting experience (or equivalent) preferred; 3-5 years of management experience preferred.
• Experience with peri- or post-approval late phase interventional studies and pregnancy/lactation studies is preferred.
• Broad experience in quantitative methods in real-world evidence and health services research, with the focus on design of non-interventional studies and data analysis using observational retrospective and prospective data.
• Strong understanding of relevant methodology and biostatistics.
• Knowledge of drug development process and international regulatory requirements.
• Proficient in MS Office; ability to read and understand SAS/STATA output; working knowledge of data analysis software (e.g., SAS, Stata, R) is a plus.
• Excellent written and verbal communication skills in English.
• Strong organizational, time-management, prioritization, and decision-making skills.
• Ability to learn and apply new information, skills, and procedures quickly.
• Proactive and positive approach to tasks and projects.
• Strong interpersonal skills with the ability to develop and sustain positive rapport with internal and external contacts.
• Experience presenting ideas to individuals and groups.
• Sound professional judgment in analyzing, responding to, and resolving enquiries, issues, and escalations.
• Ability to tailor and deliver high-level presentations to diverse audiences.
• Ability to make independent, critical decisions based on relevant information.
• Desire and ability to guide and coach junior to mid-level scientific staff.

Nice To Haves

• Degree in perinatal epidemiology, preferred.
• Minimum 5+ years of consulting experience (or equivalent) preferred
• 3-5 years of management experience preferred.
• Experience with peri- or post-approval late phase interventional studies and pregnancy/lactation studies is preferred.
• working knowledge of data analysis software (e.g., SAS, Stata, R) is a plus.

Responsibilities

• Design and implement de novo data collection studies (retrospective, prospective, and/or cross-sectional), primarily for pregnancy safety studies.
• Conceptualize advanced study designs, supervise the development of study protocols, study reports, and other scientific deliverables.
• Review statistical analysis plans.
• Ensure project completion and quality delivery.
• Work closely with other scientists, oversight directors, project leads, biostatisticians, and programmers.
• Lead interactions with clients in the pharmaceutical and medical device industries.
• Review and finalize project deliverables ensuring validity and reliability of study findings.
• Oversee budget, deliverables, and project timelines; identify scope expansion and need for amendments.
• Contribute to thought leadership, such as abstracts and manuscripts as co-author and, when possible, first author.
• Serve as a consultant to other principal investigators or staff on other projects.
• Guide and mentor staff across multiple levels.
• Lead the growth in your area of responsibility. Participate in proposals, design conceptual approaches for proposals, supervise and mentor junior staff, contribute to business development, and identify and pursue business opportunities within Evidera/PPD.
• National and international travel is expected.
• Possible managerial duties, including actively managing and/or mentoring a team of scientists.
• Participate in client calls and address questions about your work.
• Proactively identify issues and develop strategies for mitigation and/or effective solutions.
• Provide scientific consultation and use the best methods to address research needs.
• Contribute to strategic thinking and innovation.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Senior