Senior Scientist – Statistical Consulting USA
IDDI (International Drug Development Institute), founded in 1991, is a highly recognized biostatistical and eClinical data services provider in the field of clinical research, providing agile clinical trials services for pharmaceutical, biotechnology, and medical device/diagnostic companies. Together, we want to achieve one objective: support our clients to accelerate the delivery of their drugs and improve people’s health.
With over 150 talented employees located in our offices in Belgium and the United States of America, to support our continued growth we are actively looking for a Senior Scientist, Statistical Consulting. By joining a tight-knit group of highly skilled statisticians, the successful candidate will further strengthen the multinational IDDI team in Raleigh, NC, USA.
You will work alongside a team of highly skilled clinical trialists and researchers, providing consultancy and study design services to help clients apply traditional and emerging statistical methods, modeling and simulation techniques, protocol and clinical study report writing, and regulatory guidance that supports the development and execution of clinical development strategies with an eye towards precision medicine.
Senior Scientists at IDDI are integral partners to both our multidisciplinary clients and fellow IDDI colleagues, displaying resourceful and collaborative thinking to support new treatments and interventions in a diverse range of disease areas. IDDI’s culture is therapy-focused and scientifically driven: continuous development of our staff, invested research into new statistical methodology, and contribution to non-industry sponsored research (over 15% of IDDI projects are academic studies).
SENIOR SCIENTIST – STATISTICAL CONSULTING, USA
- As an active team member of the Statistical Consulting and Research team, perform consultancy tasks in a diverse range of projects involving study design, data analysis, modeling and inference, expert testimony, regulatory guidance
- Serve as the face of IDDI and main point of contact for clients in the design of clinical trials and other scientific projects requiring methodological input or requiring expert statistical support
- Provide expertise in one or more of the following areas:
- Experimental design
- Bayesian methods
- Adaptive design
- Validation of diagnostic tests, devices, and/or biomarkers
- Missing data, multiple imputation
- Historical controls
- Rare and orphan diseases
- Regulatory pathways
- Support internal operational teams in their implementation of studies and methods, including mentoring on complex protocols and area of expertise
- Assess the developmental status of new projects and identify clients’ needs
- Lead or contribute to efforts to publish (posters, presentations, manuscripts) in area of expertise and maintain active membership in key scientific societies (e.g., International Biometric Society, Society for Clinical Trials)
- Write and review statistical sections of protocols, including performing sample size and power calculations addressing unique and challenging situations
- Prepare reports summarizing consultancy findings, such as statistical modelling of endpoint selection and other study design features
- Develop SAS or R programs to perform modelling and ad hoc analyses
- Develop and maintain state-of-the-art knowledge on advanced statistical methods and standard practices in clinical trials
- Review statistical and clinical reports, including NDA, IND, BLA, and other relevant submission package materials
- Support clients in their preparation for meetings and other interactions with regulatory health authorities, such as the EMA and FDA
- Participate in business development activities to support the successful conversion of prospects into clients, including assisting in the identification and assessment of new opportunities and writing technical/research strategy sections of proposals and applications
- Serve as the voting member statistician on industry- and government-sponsored IDMCs for randomized clinical trials
- Master’s degree or Doctorate (PhD, ScD, DrPH) in (Bio)Statistics, or Master’s degree or Doctorate in another quantitative science with substantial coursework in statistics
- At least 5 years of experience in clinical biostatistics
- Fluent English
- Experience serving as a point of contact for clients
- Excellent interpersonal skills (proven communication, organizational and time management, and flexibility)
- Passionate about science and clinical research
- Motivation and ability to build client partnerships
- Knowledge of Good Clinical Practice and regulations governing clinical trials and electronic data
- Trained in SAS and R programming
- Experience using sample size and other statistical software (e.g., PASS, EAST)
- Impeccable attention to detail
- Ability to work independently
- Team player
- Problem solver
- Flexible to travel
A unique opportunity to work in a friendly, team-oriented, and stimulating environment that values integrity and innovative. You will join an international and multi-cultural company that includes over 25 different nationalities (English is the working language) and where employees are the strongest asset. We regularly enjoy company-wide social events such as BBQs, family-day outings, sports, and charity fundraisers.
At IDDI, we offer job stability and growth opportunities through on‑the‑job training and mentoring programs. Working at IDDI will bring you an expertise that is widely recognized in our industry.
Our clients value our flexibility, responsiveness, and proactive approach.
We offer a competitive salary and robust benefits package including medical, dental, and vision insurance plans, flexible spending accounts for health and dependent cares, short- and long-term disability insurance, life insurance, 401(k) retirement plan, as well as flexibility for a better work-life balance (flexible working hours, home-working opportunities, paid time off). Based on the candidate location, you could also work fully remote.
Interested in this challenging position?
Please send your CV and cover letter highlighting your motivation and relevant professional experience for the position by e‑mail at careersUSA@iddi.com (to the attention of Andrea Golder).