Manager, Statistical Programming
Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).
This Manager, Statistical Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including coordinating with external vendors as required for clinical, business, and research development.
These include developing and validating SAS programs for clinical trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously.
- Serve as a subject matter expert and provides expertise for programming.
- Perform all programming tasks required to support Data Management and Biostatistics, as necessary.
- Perform validation and QC/QA of CDISC, SDTM domain output in accordance with SOPs, SOIs, and guidance documents.
- Manage external vendors and ensure accurate and high-quality deliverables.
- Create and maintain specifications as per CDISC SDTMIG.
- Define and create ad-hoc reports and listings for clinical teams.
- Develop, implement and maintain SAS programming standards.
- Review annotated case report forms and database structures.
- Manage or lead programming assignments as necessary.
- Mentor and train other associates within Data Management, as necessary.
- Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
- Remain informed of new developments in programming that are relevant to the industry and contribute to the innovation of new reporting systems.
- Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.
- Review deliverables before transfer to either internal or external clients.
- BA/BS degree required, MS degree in statistics/mathematics desired
- Minimum of 8 years SAS and clinical programming experience in the biotech/pharmaceutical/ CRO industry
- Project management and team leadership experience.
- Knowledge of CDISC, CDASH and SDTM is a must.
- Experience with programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.
- Proficient in industry standards, medical terminology, and clinical trial methodologies.
- Drug filing experience.
- Vendor (CRO) management experience.
*Equal Opportunity Employer/Veterans/Individuals w/Disabilities
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