TITLE: Statistical Data Manager
REPORTING TO: Senior Biostatistician
LOCATION: Center for Biomedical Research, New York, NY
JOBS SUPERVISED: N/A
ASSIGNMENT LENGTH: Indefinite
The individual in this role will be responsible for data management of clinical trials at the Center for Biomedical Research (CBR).They will also validate clinical trial data sets and statistical analyses.
1. Develop clinical trial database/data dictionary; collaborate with PC clinical team to develop case report forms (CRFs).
2. Establish clinical trial database using DFdiscover or other identified software, based on CRFs and data dictionary, including formatting CRFs within relevant data collection software, implementing legal ranges, skip patterns, other logic checks and schedule of events within the study set up.
3. Ensure accuracy, completeness and integrity of data collected in clinical trials through edit checks and/or manual review of CRFs. Generate and resolve data queries. Communicate with study site staff regarding queries as needed.
4. Prepare data management documentation, e.g. annotated CRFs, data dictionary, edit check specifications, notes to file, and data management plans in consultation with study statistician.
5. Ensure that data collection tools and systems used in clinical trials are validated and meet other GCP and regulatory requirements.
6. Write and modify SAS programs to implement data validation procedures, execute edit checks and other ad hoc data quality checks
7. Write SAS programs to produce to compare data sets and analysis outputs (including tables and listings for reports) and identify any discrepancies.
8. Assist with database lock and archive of study data.
9. Collaborate with medical director as needed on adverse event, medical history and medication coding for clinical studies.
10. Collaborate on and update Standard Operating Procedures (SOPs) for data management for CBR clinical trials
We recognize that strong candidates may not have every qualification listed here, and encourage applications from individuals who bring passion, skills and experience in many or most of these areas.
1. Bachelor’s/Master’s degree in computer science, statistics, data science or related field and at least 5 years clinical data management experience
2. Experience creating relational databases
3. Clinical trial research data management experience and thorough knowledge of applicable federal regulations including GCP and 21 CFR Part 11
4. Knowledge of CDISC standards, especially CDASH, SDTM, ADaM
5. Familiarity with database validation procedures.
6. Excellent oral and written communication skills
7. Strong interpersonal skills
8. Demonstrated ability to manage multiple projects and timelines
9. Must be detail-oriented with good analytical skills and have an in-depth knowledge of SAS.
10. Demonstrated ability to work as a team member with data management, statistical and administrative staff.
11. Prior experience with DFdiscover or RedCAP a plus
SALARY AND BENEFITS: Salary range between $78,000-97,000 annually, depending on knowledge, skills and experience. Excellent benefits package includes medical, dental, vision and life insurance available immediately upon hire; 403(b) retirement plan with employer contribution equal to 12% of annual salary after one year of employment; generous annual and sick leave; and paid parental leave. We strive to provide an environment of professional growth and development.
Application Deadline: June 30, 2021
When applying through the web portal please attach your CV and Cover Letter in Word or PDF format.
The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in this position, please apply at: http://www.popcouncil.org/employment/index.asp.
The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which they are being considered. The Council especially encourages applications from members of underrepresented groups including but not limited to Black people and people of African descent, Indigenous people, people of color, women, LGBTQ+ individuals, including people who identify as transgender, non-binary, or gender expansive, people with disabilities, first-generation college graduates, and those from communities with the most to gain from expanded access to sexual and reproductive health services and information. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.