What are the responsibilities and job description for the Director, Statistics position at NWRPros?
Our client is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases and cancers.
Provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role, the Director, Statistics partners with key internal stakeholders including: clinical development, statistical programmers, global medical affairs and regulatory professionals.
What are your job responsibilities?
Qualifications
Provides scientific and statistical leadership for assigned clinical development projects. A visible and collaborative role, the Director, Statistics partners with key internal stakeholders including: clinical development, statistical programmers, global medical affairs and regulatory professionals.
What are your job responsibilities?
- Direct and provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Lead the development of protocols, statistical analysis plans, and statistical programming plan. Lead/develop statistical strategy for project development and regulatory submission.
- Represent function/department on project team(s) to provide statistical input to drug development and drive alignment with functional management. Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects.
- Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies.
- Provide sufficient detail to support and allow efficient programming implementation. Ensure software and program configuration meet requirements for producing standard tables, listings and graphs for clinical study reports and for submitting reports to the regulatory agencies.
- Develop strategy for data presentation. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
- Act as the liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees. Build external scientific connections which foster professional development and promote the reputation of the Company.
- Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents.
- Exhibit proficiency in Microsoft Office; Word, Excel, PowerPoint, and Outlook.
- Demonstrate effective verbal and writing skills.
- Provide direction to senior management in various areas and groups
Qualifications
- MS (with 7 years of related experience) or PhD (with 5 years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and excellent communication skills, both oral and written.
- Able to identify data or analytical issues, and collaborate with others to provide solutions.
- Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
- Must have the ability to build and maintain positive relationships with management and peers.
- Highly motivated to drive innovation.
- Excellent business writing and presentation skills required.
- Must display strong analytical and problem-solving skills.
- Attention to detail is required.
