Sr. Principal Biostatistician

Location
02451, Waltham
Posted
Nov 15, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Imagine a world where you could detect health issues sooner to treat them more effectively. Where food and water are always safe, even in remote corners of the earth. And where scientific and medical research are enhanced to solve the greatest challenges of our times. At PerkinElmer, we imagine this world every day. Then, we innovate and collaborate to make it happen everywhere.

Our dedicated team of about 14,000 employees worldwide, pioneers scientific technologies for better detection, imaging, and informatics to help our customers work to create healthier families, improve the quality of life, and sustain the well-being and longevity of people globally.

If you are seeking a meaningful, impactful, and stimulating career, look no further.

Responsibilities:

  • Serve as a global biostatistician lead on verification and validation study design and data analysis, overseeing internal and external statisticians in the delivery of analysis and reporting
  • Provide strategic input into the analysis of large and complex data sets from high throughput platforms
  • Maintain and expand expertise in various computing tools to leverage internal and external data sets
  • Work with cross-functional teams (R&D, regulatory, quality, etc.) to support IVD product submission, present in meetings with FDA, and provide statistical expertise to regulatory submissions and ensure quality and appropriateness of submission deliverables.
  • Build out statistical capabilities and propose opportunities for productivity improvements and implementation plans. Lead strategic statistical thinking, standardize processes and methodologies, may include developing statistical tools to aid scientists in standardized analysis.
  • Use statistical expertise to prepare both internal and external reports, presentations and manuscripts, with the aim of improving the quality of internal decision making and increase our influence on external stakeholders.
  • Author documentation for R&D DHF deliverables according to PerkinElmer Design Control Process for IVD or RUO products (feasibility plan/report, reagent/software requirements, verification & validation plan/report)

Education and Experience:

  • MS or PhD in Biostatistics, Statistics, Computational Biology.
  • >5 years with PhD (or >8 years with MS) relevant post-graduate academic/industry experience collaborating within a cross-functional team

Other Requirements:

  • Strong basis in statistical concepts and methodologies such as predictive modeling, mixed effects models, multivariate analysis, etc.
  • Understanding of design of experiments, assay development, and statistical applications for research and verification/validation, including power/sample size calculations.
  • Strong statistical programming skills with R and/or python and/or SAS
  • Knowledge of regulations required by FDA, EMA, and other regulatory bodies and standards (e.g. CLSI guideline) affecting IVDs and Biologics.
  • Experience in applied Bayesian modeling is a plus
  • Experience in data analysis from real-time PCR, NGS is a plus
  • Familiarity with validation requirements for obtaining CE-IVDR and/or FDA clearance/approval of IVD products is a plus.
  • Excellent communication, presentation, and writing skills with an ability to explain complex technical details in simple language.
  • Work well in a team as well as independently and be able to take a leadership role on the statistical aspect of various projects.

What we offer?

  • Generous Paid Time Off
  • Paid Volunteer Day – “Impact Day”
  • Paid Sick time
  • 10 Paid Holidays
  • Tuition Reimbursement - $7,500 annual
  • 401k Retirement Plan with dollar-for-dollar match up to 5% of your eligible pay
  • Employee Stock Purchase Plan
  • Various voluntary insurance benefit plans
  • Pet Insurance
  • Employee Stock Purchase Plan
  • Dental Insurance
  • Medical Plans with HSA & 100% coverage for in-network preventive care