For over 40 years, Novum has been considered one of the world’s leaders in the conduct of clinical trials; Early Phase Research from First in Human studies to large bioequivalence studies are conducted at Clinical Pharmacology units in Houston, Texas; Las Vegas, Nevada; and Fargo, North Dakota. A separate division, managing Late Phase Research requiring patient populations across multiple therapeutic areas, is lead by the Clinical Trials Division headquartered in Pittsburgh, Pennsylvania.
This position is located in our corporate offices in Pittsburgh, Pennsylvania's Station Square.
The Associate Director, Biostatistics is responsible for providing essential support to the Scientific Affairs Department by overseeing the day-to-day operational and workflow processes of the Biostatistics Department. This position leads the team of Biostatisticians, SAS Programmers and Quality Control Specialists to deliver high quality output in a timely manner. Will be responsible for identifying, establishing, and implementing good data handling practices and quality check systems throughout the department to ensure the accuracy/consistency of study results and other departmental deliverables are met. Will collaborate with a variety of team managers and members to assure completion of projects according to Sponsor expectations; and to assure required standards, processes, SOPs, and work instructions are created to support the programming and statistical activities with the group. Provides technical input to the queries from staff or other groups regarding departmental deliverables. Leads by example in an execution-oriented, smaller-company environment by performing whatever tasks and producing whatever work is necessary to ensure company and personal success.
Bachelors Degree or equivalent in Statistics, mathematics, medical or life sciences discipline with a minimum of 3 years related experience and/or training or an equivalent combination of education and experience is required. Managerial/Supervisory experience is required. Strong interpersonal skills with the ability to prioritize work flow and direct a group for ensuring study contracted timelines are met. Candidate must have a familiarity work in a SAS environmental for biostatics and programming. Understanding of the CDISC requirement for regulatory submission is preferred. Previous experience in a CRO or service organization is highly desirable.
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.