PRINCIPAL BIOSTATISTICIAN WITH CLINICAL (REMOTE)
Remote, but prefer local candidates to Gaithersburg, MD.
- This is a delivery focused role working under the leadership, oversight, and direction of assigned Client Supervisor, responsible for activities relating to design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization.
- The position requires sufficient experience working as a statistician in the pharmaceutical industry, to be able to independently perform and/or lead statistical work within a study, multiple studies, indication, or be recognised as a methodology expert.
- This individual is able to support and/or lead work either in house or partnering externally to ensure delivery to standards, quality, and time.
- May serve as a supporting or lead statistician for a study, multiple studies, indication within a project (potentially as a Global Product Statistician) or a project-level activity, such as a regulatory or payer submission, responsible for statistical elements of the design, analysis, interpretation and/or reporting.
- Quantifies the benefit, risk, value, and uncertainty of the emerging asset/product profile.
- Develops design options and provides high quality deliverables to support the business in making informed decisions.
- Contributes to statistical methodology advances by identifying new opportunities, investigating, and applying novel statistical approaches, including modelling and simulation.
- Ensures high quality is built into own and other statisticians' deliverables.
- Ensures compliance with standards and external regulations.
- Contributes to the development of best practices to improve quality, efficiency, and effectiveness within function.
- Plans and supports Team's project activities and tasks.
- Communicates and escalates risks within the assigned studies and/or projects.
- Collaborates internally and externally, to ensure delivery to standards, quality, and time.
- Provides technical knowledge as an expert for a number of statistical processes and systems through a regional based group that ensures effective collaboration between a technical services group and Client's regional sites and customers.
- Develop and build, or act as a specialist expert within, a cross-functional multi-skilled team comprised of experts across multi-disciplinary project teams.
- MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma industry.
- Very good SAS and R programming skills.
- Previous Therapy Area experience.
This 12+month position starts ASAP.
ALPHA'S REQUIREMENT #22-01566
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Job Types: Full-time, Contract
- Dental insurance
- Health insurance
- Health savings account
- Referral program
- Vision insurance
- Monday to Friday
Work Location: One location