Overview:
Develop and implement statistical analysis plans, protocols, study reports, and other statistical sections of NDAs and other drug, device, or biologic regulatory submissions. Participate in the project-specific programming of statistical tables, listings, figures, and analysis datasets for clinical trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs) set forth by PharPoint Research, Inc. and its sponsor clients.
What you will do:
- Efficiently and effectively coordinate statistical reporting activities for at least 5 active projects simultaneously which could be satisfied by 5 separate protocols, a program consisting of at least 2 separate compounds with multiple studies per compound, or NDA submission.
- Develop and review statistical analysis plans based on study specific documents and sound statistical methodology.
- Provide senior level oversight for departmental teams.
- Ensure the efficiency, quality, and integrity of analyses, data reporting, project and supervisory activities executed.
- Successfully represent the department and the company in client meetings/presentations and maintain a positive working relationship with sponsors, regulatory agencies, collaborating associates, vendor personnel and subcontract personnel.
- Develop, maintain, and produce statistical programs and specifications used in creating analysis datasets, and statistical displays.
- Comprehensive and demonstrated knowledge and understanding of statistical design and analysis methodology and statistical software.
- Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming teams.
- Demonstrate knowledge and understanding of the drug development process and FDA and ICH guidelines.
- Effectively communicate oral and written statistical concepts and results.
- Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Successful advocate of the department team approach for effective management of broad based projects such as NDA submissions or complex, multi-protocol programs potentially coordinating activities.
- Efficiently manage project budgets to identify resourcing or scope of work changes.
- Provide accurate and timely project status updates to other team members, colleagues, and senior management.
- May attend related continuing education programs, professional meetings, and/or company career development activities sponsored or approved by the company.
- Serve as a model to departmental subordinates as it relates to effective time management, communication, and utilization of resources. Provide leadership and motivation to departmental personnel.
- Provide senior leadership and guidance to departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures.
- Manage activities of assigned project team(s) to ensure effective performance of a clinical trial program. Provide direction to team members working toward a common goal and successfully coordinate multiple priorities.
- Interact collaboratively with staff across departments to ensure that project and departmental activities are successfully completed.
- May participate in the interview and selection of qualified personnel.
- Assist in the development, implementation, and delivery of departmental training programs; serve as a mentor to junior level statisticians.
- Assist in the development, maintenance, and communication of departmental systems and SOPs.
Qualifications:
- Education: Doctorate degree (PhD) in Biostatistics or related field
- Experience: 5+ years related clinical research experience, preferably at a CRO.
- Certification/Licensure: None.
- Other: Understanding of the drug development process and FDA and ICH Guidelines required. Understanding of basic and complex statistical design, analysis, and programming techniques utilized in clinical research required. Effective oral and written communication of statistical concepts and results required. Effective team player: willingness to go the extra distance to get results, meet deadlines, etc. Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change. Knowledge of one or more statistical software packages used to conduct statistical analyses required. Ability to read, write, speak, and understand English required.
Employer Statement
We’re in the business of helping clients improve global health. We’re proud to offer more than just a stable paycheck - we foster an environment of understanding, and value a better work-life balance. Here, your voice matters. Our teammates are innovative, industry-leading professionals and experts in their fields. Together, we do big things. Join us today as we work together towards a healthier tomorrow.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
PharPoint is unable to sponsor work visas at this time.
