Director, Clinical Reporting
Remote
Full Time
Experienced
Position Description:
The Director, Clinical Reporting directs, develops, and leads multiple teams of clinical reporting SAS programming professionals in the production programming for regulatory submissions and publications.Director, Clinical Reporting is responsible for contributing to the business development and marketing of the company on a regular basis.
Director, Clinical Reporting is responsible for contributing to recruiting, hiring and onboarding of staff on a regular basis.
Specific responsibilities can include:
- Manage production reporting including development and validation programming for Phase I-V clinical trials, ISS, ISE, Registries, Publications or other related regulatory submissions;
- Development, implementation and management of the Statistical Computing Environment (SCE);
- Assist in recruiting and hiring;
- Manage multiple client teams;
- Perform SAS programming and analysis support of the generation of analysis datasets, statistical analysis, listings, figures and tables;
- Perform validation of SAS programs and deliverables;
- Work directly with client managers;
- Work directly with client external vendors;
- Assist the Marketing & Sales process in new business development;
- Recommend and implement improvements in reporting standards and reporting business process;
- Recommend and implement improvements in technologies related to statistical reporting;
- Implement project management methodology;
- Set project priorities and timelines;
- Advise team members in the achievement of schedules and deliverables;
- Ensure that team uses client programming processes and programming environment properly;
- Interface with cross-functional team members;
- Onboard, mentor, supervise and train staff;
- Provide budgetary input on projects;
- Develop, publish and present white papers and presentations at industry conferences;
- Establish Navitas Data Sciences as the industry authority on clinical reporting and supporting information technology;
- Act as an Expert in three or more areas that may include Project Management, SCE, SDTM, ADaM, define.xml, SAS programming, deliverables process, Tables, Graphics, PK/PD, Registries, SCE or other areas; and
- Develop and contribute to the best practices of Navitas Data Sciences.
- Excellent management, interpersonal, communication, and organizational skills;
- Ability and desire to interface with senior management and executives in client engagements and industry associations;
- Bachelor’s degree in computer science, statistics, or equivalent; master’s degree preferred;
- Working knowledge of CDISC, SDTM, and ADaM;
- Expert knowledge of SAS-based statistical programming and Statistical Computing Environments (SCEs);
- 15 plus years Pharmaceutical or CRO industry experience in clinical reporting and statistical programming;
- Minimum of 10 years’ project lead/project management experience managing projects and/or staff;
- Minimum of 8 years working at Navitas Data Sciences; and
- Background in statistics and statistical analysis is desirable.
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