Applied Statistics, Biometrics/biostatistics, Operations research
SSS, a DLH Corporation company, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH’s portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.
SSS is seeking a Senior Biostatistician to join a multi?disciplinary team that conducts clinical trials and population-based research studies on behalf of government and commercial clients. The ideal candidate will have expertise in the design and analysis of clinical trials and an understanding of the latest statistical and methodologic developments in the field. Experience in the design, analysis, and reporting of epidemiologic studies is highly desirable.
You will be part of a collegial group that includes other statisticians, epidemiologists, data managers and programmers, and operations staff. Senior Statisticians play a critical role in study design, protocol and analysis plans development, trial reporting, and mentorship of junior analysts. The studies you will support are focused on significant medical and public health problems, so your contributions will make a real difference to population health. The position also offers opportunities for leadership, professional development, innovation, collaboration across disciplines, and publication.
Participates in all aspects of the statistical consulting with minimal supervision
Develops or reviews design, analysis, and reporting sections for protocols
Performs power and sample size calculations
Writes or contributes to the creation of statistical analysis plans (SAP)
Develops and provides specifications for CDISC (i.e. SDTM and ADaM) compliant datasets
Tests and validates SAS programs through various methods, including independent programming
Performs quality review of statistical output, reviews for accuracy and compliance with specifications, FDA requirements and industry guidelines
Produces graphical and tabular output using SAS, R, and other programs
Researches innovative statistical methods for study design and analysis to enhance clinical development strategies for clients
Works with the Quality Management Office to maintain appropriate statistics documentation and SOPs
PhD in biostatistics or other related field plus 3 or more years of health research experience or Master’s degree in biostatistics or other related field plus 5 or more years of health research experience
Experience with early to late-phase clinical trial development, experience with adaptive platform trials preferred
Experience presenting to DSMBs preferred
Familiarity with ICH guidelines, CDISC standards and FDA/EMA guidance
Experience creating and validating SDTM and ADaM datasets from specifications and utilizing Pinnacle21 (formally OpenCDISC)
Familiarity with creating a Define-XML and Analysis Dataset Reviewer’s Guides
Experience programming tables, listings, and figures for clinical trial analysis and reporting
Experience developing SAPs and other study documentation
Ability to collaborate effectively with non-statisticians and project managers, and to work independently with minimal guidance, and as part of a multi-disciplinary team
Proficient knowledge of SAS/BASE, SAS/SQL, SAS/STAT, SAS GRAPH, and SAS Macro Language
Experience with R, Stata, SUDAAN, Python, and other applications is highly desirable
Effective oral and written communication and interpersonal skills
Ability to manage multiple projects simultaneously in a fast paced, highly collaborative environment
DLH is committed to fostering a diverse workforce and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, or protected veteran status and will not be discrimated against on the basis of disability.
Internal Number: 1941
DLH provides technology-enabled business process outsourcing and program management solutions, primarily to improve and better deploy large-scale Federal health and human service initiatives. DLH delivers professional healthcare and public services to several Government agencies including the U.S. Department of Defense, U.S. Department Health and Human Services, U.S. Department of Veterans Affairs, National Institutes of Health (NIH), Centers for Medicare and Medicaid Services (CMS) and many more.