09 Sep
|
Regeneron Pharmaceuticals
|
Western Australia
09 Sep
Regeneron Pharmaceuticals
Western Australia
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with responsible diseases.
We are seeking an Associate Director to join our Biostatistics team.
The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.
The incumbent will represent statistical issues in regulatory agency meetings.
The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in skilled associations, conferences, and publications.
As an Associate Director, the incumbent will be responsible for mentoring and overseeing less experienced statisticians, with the potential to manage full-time staff.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Work Location: Tarrytown, NY or Warren, NJ 4 days per week on site
Discover your role:
Represent Biostatistics at Global Clinical sub-teams.
Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
Lead contributions to the preparation of material to be used in regulatory interactions, including drafting analysis plan and reviewing TFLs to be used in regulatory meetings, slides for advisory committee meetings, etc.
Lead and contributes to process improvement and technical working groups and sets timelines and expectations for the deliverables.
Authors new/revised SOPs and contributes to cross-functional EPIC workstreams.
Evaluate appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.
Co-presents findings to management.
Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.
This role requires:
PhD or equivalent degree in statistics/biostatistics with >6 years of experience in the pharmaceutical industry OR MS degree in statistics/biostatistics with >11 years of experience
Preferred: Hematology, IO, non-oncology, Multiple Myeloma experience or similar Therapeutic Area.
Time to Event (TTE) experience.
Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
Solid knowledge of statistical analysis methodologies, experimental and clinical trial design Expertise in statistical software #Regnbiostats
We are committed to building a workplace with an inclusive culture.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community,
familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate.
In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
annual bonuses or other incentive plans
equity awards
pension or retirement benefits
401(k) company match
health and wellness programs
fitness centers
insurance benefits (e.g. medical, dental, vision, life and disability)
paid time off
family support benefits
Salary Range (annually) $176,****** - $287,******
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in ****, Fast Company's Best Workplace for Innovators in ****, and Forbes JUST companies in ****, among others.
#J-*****-Ljbffr
📌 Associate Director, Biostatistics - Genetic Medicine (Western Australia)
🏢 Regeneron Pharmaceuticals
📍 Western Australia