Director of Statistics

Medidata Solutions, Inc.; New York (NY); Hybrid; USD 185,000 - 246,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Life insurance

Disability insurance

401(k) matching

Family leave

Flexible PTO

10 paid holidays per year

Job summary

Medidata Solutions, Inc. is seeking a highly experienced statistician to lead and deliver statistical expertise for clinical development projects.

The role involves designing and analyzing clinical trials, developing protocols, and collaborating with cross-functional teams within Medidata's enterprise data ecosystem. Reporting to the VP of Statistics and Regulatory Science Innovation, you will contribute to strategic priorities, support client-delivered projects, and guide junior statisticians

Qualifications

• 6+ years experience as statistician in clinical development with PhD in biostatistics, statistics, or related field.
• Alternatively 10+ years experience as statistician in clinical development with Masters degree in biostatistics, statistics, or related field may be considered.
• Solid knowledge of typical drug development processes and regulatory interactions; oncology experience is a plus.
• Strong organization and leadership abilities; excellent written and verbal communication skills.

Responsibilities

• Design, analyze, and interpret clinical trials and clinical research.
• Develop and support innovative approaches to optimize trial conduct and science.
• Provide statistical expertise including protocols, analysis plans, and data analyses.
• Create and review statistical analysis plans and related documents.
• Collaborate with vendors and Medidata groups to verify data accuracy for projects.
• Present findings at meetings or in written reports.
• Work in a fast-paced environment and manage multiple projects.

Skills

Statistical analysis

Clinical development

Leadership

Communication skills

Education

PhD in biostatistics or related field

Masters in biostatistics or related field

Job description

Location

This is a hybrid remote/in-office role. Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week following Company policy.

About our Company

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating over 25 years of ground-breaking technological innovation across more than 38,000 trials and 12 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million registered users across approximately 2,300 customers trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com. Listen to our latest podcast, from Dreamers to Disruptors , and follow us at @Medidata.

About the Team

Reporting to the VP, Statistics and Regulatory Science Innovation, you will provide statistical and medical development expertise to lead customer deliveries or strategic CDRI projects. Project teams may include junior statisticians, statistical programmers, and administrative support.

Responsibilities

• Strong ability in the design, analysis, and interpretation of clinical trials and clinical research
• Assist in the development and support of innovative approaches to optimize the conduct and science of clinical trials, including use of synthetic control arms.
• Provide statistical expertise including but not limited to research in statistical methods, development of statistical sections of protocols or analysis plans, participation in scientific publication or presentation, and data analyses for individual projects or larger synthetic controls programs. Medidata has access to patient level data from thousands of previous clinical trials in the Medidata Enterprise Data Store (MEDS) which may be the basis for this work.
• Create and review protocols, statistical analysis plans, and other clinical trial related documents.
• Work collaboratively with vendors and other Medidata groups to assist in evaluating the accuracy of standardized historical data for each project assigned
• May present at internal or external meetings or communicate findings through written reports
• Strong statistical skills, particularly in propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
• Ability to work in a fast paced environment and work on multiple projects at the same time
• Awareness of regulatory and industry expectations and practices
• Support customer deliveries
• Support and develop CDRI strategic priorities
• Other duties as assigned

Qualifications

• 6+ years experience as statistician in clinical development with PhD in biostatistics, statistics, or related field
• Alternatively 10+ years experience as statistician in clinical development with Masters degree in biostatistics, statistics, or related field may be considered
• Solid knowledge of typical drug development processes, including for example the regulatory interactions expected at each phase of development and the level of evidence generally required for approval of a new medical product, experience in the oncology therapeutic area is a plus
• Strong organization and leadership abilities
• Excellent written and verbal communication skills

The salary range posted below refers only to positions that will be physically based in New York City. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than New York City, may differ based on the local market data in that region.

The salary range range for this position physically based in NYC/ NJ Metro Area is $184,600 - $246,000.

Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Many of Medidata's non-sales positions are eligible for annual bonuses.

Benefits

• medical insurance
• dental insurance
• life insurance
• disability insurance
• 401(k) matching
• family leave
• flexible paid time off
• 10 paid holidays per year

Equal Employment Opportunity

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.