The Senior Biostatistician is responsible for performing statistical analysis to support Phase I and clinical endpoint studies performed or managed by Novum PRS. Will develop, write and/or review statistical analysis plans and review statistical/results sections of study protocols and reports. Will discuss study designs and results with sponsors via written and/or oral communication as required during progress of the study. Will maintain updated knowledge in the scientific and statistical concepts and in methods and techniques, and maintain appropriate statistical applications for company’s research interests. Responsible for identifying and implementing good scientific and data handling practices throughout the company to ensure the highest quality of product to our clients.
Master’s Degree or equivalent in statistics or life sciences with a strong statistical component; at least 8 years of related experience and/or training, or an equivalent combination of education and experience is required. Candidate must possess a background in SAS procedures and programming, and experience with Microsoft Operating Systems. A minimum of five years experience with SAS is required. Must be willing to travel both within the USA and overseas to represent Novum in front of clients and attend scientific meetings and trade events. Previous experience in a CRO or service organization is preferred.
Novum is a contract research organization ("CRO") that provides clinical research, data management, statistical and reporting services to the pharmaceutical and related industries. Novum was founded in 1972 and operates Phase I research facilities with a total of 550 beds in three USA locations. Novum is the second largest CRO in the USA as, measured in bed capacity. Novum averages over 200 Phas...e I studies performed annually.
Novum maintains a highly-experienced management team and staff with the capabilities to perform a wide range of Phase I clinical trials. Although most Phase I studies are conducted with oral dosage formulations, Novum has developed expertise in performing studies with non-traditional delivery systems such as topical transdermal, nasal, inhaled, rectal, vaginal, and intravenous routes of administration. Novum is the world leader in vasoconstrictor studies of topical corticosteroids for both generic and innovator drugs. Further, we are a leader in performing pharmocokinetic (PK), irritation, sensitization, and adhesion studies with transdermal and topical dosage forms.
Novum’s rapidly growing clinical trials management and data management groups, currently focus on performing Phase II through IV clinical endpoint studies requiring large patient populations in non-serious disease states that are treated in an outpatient setting. Examples would include for example many dermatological diseases, allergies, vaccines and diabetes.