Flatiron Health
Reimagining the infrastructure of cancer care.
New York, NY

Head of Regulatory Projects, Quantitative Science

Sorry, this job was removed at 11:47 a.m. (EST) on Saturday, April 11, 2020
Find out who's hiring remotely in Greater NYC Area.
See all Remote Operations jobs in Greater NYC Area
Apply
By clicking Apply Now you agree to share your profile information with the hiring company.

We are looking for a senior leader with expertise and experience in a quantitative research field to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here is what you need to know about the role, our team and why Flatiron Health could be the right next step in your career.

What you’ll do

The regulatory early scoping team steps in very early in the lifecycle of a project to scope the project and collaborate on the regulatory strategy and process. At a macro level, this involves helping the sponsor develop a core strategy on the regulatory, data fitness and analytical aspects of a potential future regulatory submission. We are looking for a senior quantitative scientist leader with experience in regulatory submissions in drug development to provide the technical and strategic leadership, training and collaboration with our customers and regulatory agencies. Furthermore, as a lead, you will work with your Quantitative Sciences team members to answer some of the most important questions in cancer research and drug development using Flatiron’s unique, large real-world dataset. As a leader on this team, you will:

  • Have a deeper understanding of the clinical questions of interest and the sponsor’s regulatory strategy 
  • Be the point of contact and accountable for Assess project feasibility (e.g. patient counts, availability of desired data elements, etc)
  • Generate, review and provide recommendations on the analytical strategy 
  • Collaborate with a wide array of customers and on a variety of regulatory use cases (e.g. label extensions, PMCs, etc)
  • You will be expected to have a solid understanding of our data models and RWD-appropriate analytic methods, which may need you to spend some time coding in R. You will also receive the support of a junior QS team member to do more of the hands-on coding needed for the projects
  • Collaborate with a team of oncologists, product and operation managers, clinical data experts, regulatory and compliance specialists, and software engineers to discuss QS capacity around resourcing (collaborate with management to provide optimal resourcing for the projects), scoping of new projects, escalation of project issues, ensuring data quality standards, and team’s strategic vision
  • Develop and manage relationships with external partners including life science companies, regulatory agencies, academic institutions and health technology assessment bodies to advance the integration of our analytic products through demonstrated value. As needed participate in regulatory meetings (FDA/EMA) 
  • As a senior QS team member, have a leadership presence at scientific conferences and meetings by making presentations, organizing sessions, and leading discussions that advance the field of Real-World Evidence (RWE) research
  • People management: Mentoring and coaching other QS members within the team is considered a must in this role. Formal people management is not a requirement for the QS lead, however, if a candidate is interested and has the skills to manage a small group of individuals that would be a plus


Who You Are

You are an analytical thinker with 5+ years of work experience in an academic or industry setting. You are excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You are a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact. 

  • You hold a Masters or PhD in a quantitative discipline such as biostatistics, epidemiology, applied statistics, health economics, or a related discipline
  • You are an experienced statistician from Pharma who has experience with regulatory submissions (e.g FDA and EMA)
  • You have experience collaborating with researchers in the life science industry, academia, or government agencies
  • You are a natural teacher; you have a passion for mentoring and teaching those of various backgrounds and levels of experience
  • You have drug development experience and are able to understand or relate to the sponsor’s research questions and development strategy
  • You have the ability to juggle multiple external interactions and deadlines simultaneously and the adaptability to collaborate with individuals at all levels and functions
  • You have excellent written and oral communication skills and a deep attention to detail
  • You are comfortable with doing some level of hands on work, R coding (approx 20%)
  • You are self-motivated, self-directed and proactive
  • You can represent the data and analysis strategy, and get in the technical weeds to explain to our customers
  • You are willing to travel (approximately 5-10%)

 If this sounds like you, you'll fit right in at Flatiron. 

Extra Credit 

  • You have oncology experience
  • You have healthcare consulting experience
  • You have experience working with longitudinal EMR data
  • You have experience working with life sciences companies or health-related government agencies (e.g., CDC, NIH, or FDA)
  • You have people management experience

Why You Should Join Our Team

A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Researchers, data scientists, designers, clinicians, technologists and many more all work together to improve cancer care and accelerate research.

You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer: 

  • Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
  • Career coaching opportunities
  • Hackathons for all employees (not just our engineers!)
  • Professional development benefit for attending conferences, industry events and external courses
  • Work/life autonomy via flexible work hours and flexible paid time off
  • Generous parental leave (16 weeks for either parent)
  • Back-up child care
  • Flatiron-sponsored fitness classes

Flatiron Health is proud to be an Equal Employment Opportunity employer. 

We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.


See More
Apply Now
By clicking Apply Now you agree to share your profile information with the hiring company.

What are Flatiron Health Perks + Benefits

Flatiron Health Benefits Overview

At Flatiron, we are committed to providing our employees with the resources they need, both within and outside of work. This enables them to concentrate their working hours on improving cancer care and accelerating cancer research, while dedicating their non-working hours to everything else life has to offer.

We offer a full range of benefits to support our employees and their families. These benefits include health and wellness, family planning, financial planning and time away.

Culture
Volunteer in local community
Partners with nonprofits
Open door policy
OKR operational model
Team based strategic planning
Open office floor plan
Employee resource groups
Hybrid work model
Employee awards
Flexible work schedule
Remote work program
Diversity
Documented equal pay policy
Dedicated diversity and inclusion staff
Mandated unconscious bias training
Diversity manifesto
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
401(K) matching
Company equity
Performance bonus
Pay transparency
Child Care & Parental Leave Benefits
Childcare benefits
Generous parental leave
Family medical leave
Adoption Assistance
Return-to-work program post parental leave
Company sponsored family events
Fertility benefits
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
Paid holidays
Paid sick days
Flexible time off
Company-wide vacation
Office Perks
Commuter benefits
Free snacks and drinks
Some meals provided
Relocation assistance
Meditation space
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Customized development tracks
Personal development training
Apprenticeship programs

More Jobs at Flatiron Health

Apply Now
By clicking Apply Now you agree to share your profile information with the hiring company.
Learn more about Flatiron HealthFind similar jobs like this