Description:

Oversee data management and statistical analysis support for the clinical research activities conducted HIV Research Program (MHRP), the Emerging Infectious Diseases Branch (EIDB), and other affiliated programs.

Must have clinical data management experience

Must have some clinical trial experience (study design, sample size and power calculations, statistical analysis plans/reports)

The incumbent is responsible for ensuring the complete and accurate collection of research data from all clinical research sites. The incumbent also oversees a staff of clinical data management specialists, programmers, and data analysts that are tasked with the creation and implementation of tools to support data capture, routine monitoring of data for completion and accuracy, communication with clinical research sites to coordinate data entry and response to database queries, preparation of data reports, and design and execution of statistical analyses to test research hypotheses. The incumbent is responsible for directing and coordinating the completion of all responsibilities assigned to DCAC while ensuring that all necessary steps are taken to comply with regulatory requirements and ensure data integrity.

Directs and leads all activities of the Global ID Data Coordinating and Analysis Center (DCAC), supervising a team that includes clinical data management specialists, programmers, and data analysts.

Assigns research protocols and delegates related responsibilities to DCAC staff, ensuring that all DCAC staff are aware of their accountabilities, responsibilities, and deliverables.

Develops and maintains an excellent working relationship with Global ID scientific staff, collaborators, and other organizations.

Maintains a team of professionals with sufficient expertise to execute the DCAC mission through identification of personnel needs, recruitment and retention of highly-qualified staff, and provision of performance evaluation feedback.

Evaluates and acquires tools to optimize data collection and analysis as needed.

Monitors the accuracy and completeness of data included in Global ID research databases and develops systems to enhance the integrity of these data.

Provides relevant program status reports to the institution, regulatory agencies, funders, and other entities.

Designs and implements statistical analyses in consultation with Global ID investigators and collaborators.

Contributes to the preparation of scientific papers for presentation and local and national meetings and for publication in medical and scientific periodicals.

Adheres to a policy of strict confidentiality concerning all documents, data, and information maintained within DCAC.

Develops computing infrastructure plans in accordance with long- and short-term program objectives; directs systems evaluations; plans, installs, tests, and coordinates the corresponding systems/software changes.

Oversees the development and management of a relational database (big data warehouse) to harmonize data and specimen tracking across multiple studies.

Forecasts budgetary needs and monitors expenditures against contract, departmental, and project-specific budgets.

Additional Skills & Qualifications:

Doctoral Degree preferred within Epidemiology, Biostatistics, Statistics, or a related field

10 years of experience

Responsible for oversight and management of DCAC, including supervision of data management specialists, programmers, and analysts.

Thorough knowledge of data management and biostatistical methods

Clinical Trials experience

Proficiency in data analyses using statistical tools such as SAS, Stata, and GraphPad Prism

Awareness of data quality issues

Experience in the analysis of clinical cohort and clinical trial data

Experience managing multi-disciplinary teams

Ability to lead and direct staff to meet mission requirements

Familiarity with medical science and clinical research

Ideally with experience in HIV and other infectious disease research

Ability to communicate effectively

Ability to use sound judgment in solving problems

Ability to learn new systems necessary for job completion

Ability to make effective presentations and publish scientific research

Excellent verbal, written and interpersonal communication skills

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

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The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.