Director of Clinical Research
Zipongo makes eating well easy. We’re a 30-person digital health company on a mission to reduce chronic disease by positively impacting the one thing everyone does each day: eat. We empower individuals by providing convenient, affordable and healthy solutions around food that enable them to enjoy their lives with friends and family.
Zipongo works with employers, health plans and other wellness partners looking for an easy way to engage their members in healthy and sustainable eating habits at work and at home. We deliver individualized recommendations tied to convenient, real-time actions including worksite cafe recommendations, healthy recipes, meal planning tools as well as discounts and incentives for healthy groceries. Our HIPAA-secure products are available on web, mobile and tablet.
About The Role
Serves as leader of the scientific team and on clinical studies. The role will oversee and manage a variety of client based clinical analysis projects. Critical skills for this position are the ability to understand the scope and deliverables of a project and to prepare a project plan, timeline and budget. The Clinical Research Director will be responsible for day-to-day management of all aspects of biostatistical queries for the subscribers within his or her portfolio. This may include abstract preparation, management of the publication process and manuscript development, management of staff assigned to the projects, documentation and quality control. Co-authorship on publications (abstracts and manuscripts) is expected with this position. This position reports to the Chief Medical Officer.
- Act as the lead statistician on clinical research projects
- Provide statistical expertise for study design of clinical trial protocols
- Maintains the statistical integrity of the clinical trials being conducted
- Write statistical methods section of the study protocol
- Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
- Program summary tables, data listings and graphical representations of clinical trials data
- Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
- Prepare data deliverables and key sections of clinical study reports and various regulatory documents
- Provide statistical support to answer questions from external clients (such as FDA, Investigators)
- Contribute to the development of standard operating procedures for clinical trials
- Represent statistical operations department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
- Comply with Zipongo’s data integrity & business ethics requirements
- Perform other related duties incidental to the work described herein
- Excellent analytical skills, with the ability to process scientific and medical data
- Able to work independently
- Excellent knowledge of statistical programming; Expertise in manipulating and analyzing SAS data
- Ability to identify data issues, present problems, and implement solutions.
- Develop project timelines, procedures, forms and tracking systems
- Maintain project documentation and track progress on projects
- Participate in the preparation of literature reviews, proposals, manuscripts, project reports, presentations of study design and findings
- Strong interpersonal communication and presentation skills; As required, the Clinical Research Director will represent the company at client meetings, professional meetings, and symposia
- Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
- Good leadership, organizational and time management skills, with the ability to multi-task
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
- Ability to effectively collaborate across cross-functional teams
Education or Equivalent Experience:
- Master’s degree in biostatistics, epidemiology statistics or other related, scientific field and five years of relevant professional experience; or an equivalent combination of relevant education and/or experience. A PhD in biostatistics, statistics, or other related, scientific field is preferred.
- Must be very familiar with RCTs, longitudinal or observational registry data; preferably has conducted and published an RCT.
- Strong scientific, leadership and communication skills as well as a strict adherence to strong ethical business and research practices
- Comfortable with fast-paced environment and able to simultaneously work on several projects
- Must be self-motivated, highly organized and detail-oriented, with excellent time management skills
- Must possess strong English communication and writing skills and be able to work independently and as part of a team
- Requires a strong working knowledge of MS Office, Word, PowerPoint, Excel, Access, MS Project, and SharePoint; A strong working knowledge of SAS or other analytical software programs is preferred.
Benefits & Perks:
- Generous paid time off (3 weeks vacation, Christmas to New Year's week off, sick pay) as well as flexible working hours
- Health insurance
- Lunches and office snacks
- Relocation assistance available