Senior R&D Biostatistician
Senior R&D Biostatistician
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1 Vacancy
Job Description
We are seeking a Senior Biostatistician to join the R&D New Product Development team. The candidate will bring biostatistical skills in combination with knowledge of diagnostic product development and licensing (USDA preferred) to support the development and licensing of new products for diagnostic testing applications. The role as a Technical Product Registration Biostatistician provides a chance to participate as part of a technically focused R&D team with close collaboration with others in R&D Regulatory Affairs and the Commercial Medical Organization. This role requires a seasoned experienced professional with a full understanding of area of specialization. This job is a fully qualified career-oriented journey-level position.
The successful candidate will develop and recommend appropriate statistical methodology experimental structure analysis and data visualization utilizing statistical software and other tools for USDA and international licensing protocols studies and reports. The candidate will help to design/generate study protocols and reports for the licensing of diagnostic assays. To be successful in this role the candidate should be highly motivated detail oriented and excel in a highly collaborative and multi-disciplinary environment. They will also be expected to consistently apply discretion and sound judgement towards the work they undertake and resolve a wide range of issues in creative ways. Degree of complexity will vary between products and the level of autonomy granted will depend on the level of product/study experience.
***At this time we will not be able to offer sponsorship for this role either now or in the future.***
What will you do
Develop and recommend statistical designs methods and procedures for USDA and international product registration protocolsincluding the associated data submission packages critical for successful licensure of new diagnostic products.
Develops recommends and contributes to statistical designs methods and experimental structure data analysis and data visualization for design development verification and validation of new products to ensure the quality and timeliness of the new product development (NPD) process.
Develops recommends and contributes to statistical designs methods and experimental structure for field trials beta testing and complex validation and/or reliability testing.
Contributes to defining standard statistical designs for experimental practices based on established USDA and international product licensing guidelines for NPD and R&D.
Collaborates with NPD Design and Development Teams Process Development Teams R&D Engineering Regulatory Affairs and other internal and external stakeholders.
Analyzes summarizes and presents information and data in text and graphical forms for discussion and decision making within the organization. Presents ideas data and analysis to other parts of the organization for feedback on feasibility and concept.
Assists project teams within NPD determining critical design inputs experimental structure and establishing best practice. Works with technical leads core team leads and other project managers.
What do you need to succeed
PhD preferred with 3-5 years of relevant experience or MS with 6-8 years of relevant experience
Relevant experience in a regulated bio-tech industry is required.
Knowledge and experience with statistical programming (SAS R etc.) and proficiency with EXCEL and JMP/Minitab or equivalent statistical software.
Knowledge of standard statistical methods generalized linear models categorical data analysis survival analysis sample size determination and experimental design including response surface mixture designs fractional factorial screening designs split plots and full factorials.
Results oriented self-starter with good analytical and problem-solving skills. Demonstrated ability to work collaboratively with research and engineering teams. Ability to frame a complex scientific question appropriately develop an analytical strategy assemble the relevant data and results to clearly communicate a coherent set of conclusions.
Demonstrated ability to produce written reports that succinctly describe the study purpose experimental structure statistical analysis conclusions and recommendations. Excellent skills in data communication and visualization.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Work context involves novel and variable situations requiring analytical and creative thinking.
Strong ability to work collaboratively with regulatory agency statisticians. Excellent teaching ability: can communicate complex statistical methods and results in a manner that is understandable to recipients of statistical analyses.
Demonstrated ability to influence without authority. Strong communication and interpersonal skills. Ability to plan both short- and long-term schedules to achieve goals.
Management experience a plus.
***At this time we will not be able to offer sponsorship for this role either now or in the future.***
What you can expect from us:
Salary range starting at $100000based on experience
Opportunity for annual cash bonus
Health / Dental / Vision Benefits Day-One
5% matching 401k
Additionalbenefits including but not limited to financial support pet insurance mentalhealth resources volunteer paid days off employee stock program foundation donationmatching and much more
Ifyourelooking for a rolethatllchallenge you offer a variety of work and learning while helping an amazing industrywedlove to hear from you!
Why IDEXX:
Were proud of the work we do because our work matters. An innovation leader in every industry we serve we follow our Purpose and Guiding Principles to help pet owners worldwide keep their companion animals healthy and happy to ensure safe drinking water for billions and to help farmers protect livestock and poultry from disease. We have customers in over 175 countries and a global workforce of over 10000 talented people.
So what does that mean for you We enrich the livelihoods of our employees with a positive and respectful work culture that embraces challenges and encourages learning and discovery. At IDEXX you will be supported by competitive compensation incentives and benefits while enjoying purposeful work that drives improvement.
Lets pursue what matters together.
About the job location:
If youre thinking about relocating for this role here are a few things to know about living in Maine (often called Vacationland). The Westbrook ME area provides great access to active downtown areas and the outdoors with the coast and numerous mountains and hiking trails nearby. Youll also find a number of large companies like ours in the area creating a vibrant work culture.
You can learn more on the Portland tourism website: values a diverse workforce and workplace and strongly encourages women people of color LGBTQ individuals people with disabilities members of ethnic minorities foreign-born residents and veterans to apply.
IDEXX is an equal opportunity employer. Applicants will not be discriminated against because of race color creed sex sexual orientation gender identity or expression age religion national origin citizenship status disability ancestry marital status veteran status medical condition or any protected category prohibitedby local state or federal laws.
While we appreciate our staffing partners we are unable to accept unsolicited agency resumes.
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Required Experience:
Senior IC
Employment Type
Full-Time
