We are presently hiring a Senior Manager, Bio-statistician for our Real-World Evidence practice located in Gaithersburg, MD (remote based is an option). We are looking for a capable, motivated, and flexible candidate who enjoys variety to join our highly experienced team of bio-statisticians, epidemiologists, and SAS programmers.
The successful candidate will directly contribute to late phase and/or post-approval studies (e.g., observational studies, registries, secondary database analyses)
This position can be based in our Gaithersburg, MD facility - or remote based depending on experience.
• Understand Client Requirements: Participates in defining how the project will be performed and the deliverables that will be presented. • Prepare Proposals: Reviews and revises draft proposals that respond to client requirements following standard formats used for previous engagements. • Supervise Data Collection and Analysis: Identifies sources and obtains information from knowledgeable individuals, reference texts, on-line databases, and other research sources. Evaluates data using quantitative methods as necessary to allow appropriate inferences and conclusions to be drawn. • Review Summaries: Reviews and advises on analyses of key points, patterns, and trends found in data. • Develop Findings and Recommendations: Assists in using information and data to prepare specific findings and recommendations, which are appropriate to client requirements. • Interface with Internal Project Management and Client: May meet with client to review work plan, schedule meetings, describe data sources, explain patterns observed in data, and indicate how findings and recommendations were developed. • Prepare and Present Deliverables: Prepares written protocols, analysis plans, memos, correspondence, and reports; conducts in-person presentations for clients. • Evaluate Engagement: Participates in the evaluation of client engagements to review the original work plan, budget, consultant contributions, client responses, and the potential for future work. • Generate Repeat Business: Establishes business relationship with clients that results in repeat business for the Company. • Train and Mentor Staff: Act as a mentor to less experienced consulting staff, orienting them on company policies and career development objectives.
Doctoral degree in Bio-statistics
Good understanding of the clinical trial process and late phase/observational studies (e.g., Phase IV, registries, retrospective chart review, time and motion studies).
Good understanding of basic study designs (e.g., cross sectional, parallel group).
Able to lead protocol and analysis plan development
Able to oversee junior bio-statisticians and SAS programmers
Able to write and review SAS code for complex models
Good understanding of CDISC standards (SDTM, ADaM)
Able to write reports and publications
Communicate effectively with global internal and external team members.
Strong project and budget management experience
Working knowledge of Microsoft Word, PowerPoint and Excel.
Experienced candidates with a doctoral degree should have 7+ years of experience in consulting on Phase III clinical trials and/or late-phase observational studies/registries.
Strong knowledge of standard and advanced statistical techniques, especially in relation to observational studies.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
Covance, the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real® by providing high-quality nonclinical, clinical and commercialization services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with... drug development. Because of our broad experience and specialized expertise, we’re in a unique position to supply insights that go above and beyond testing -- We have helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today.
We also offer laboratory testing services to the chemical, agrochemical and food industries and are a market leader in toxicology services, central laboratory services, discovery services, and a top global provider of Phase III clinical trial management services.
Together with our clients, we create solutions that transform potential into reality.