Description
Summary:Provides statistical expertise to support all phases of clinical trials and regulatory submissions. Provides statistical expertise in areas that are of particular interest in oncology related trials. May be required to provide some leadership of the processes involved.
Essential/Primary Duties, Functions and Responsibilities:
- Participates in protocol development by identifying issues/solutions related to design, statistical methodology, and regulatory requirement.
- Prepares Statistical Analysis Plan (SAP), including shells for tables/listings/figures.
- Manages the generation and implementation of the prospective analysis; suggests and performs exploratory analysis for study report and/or for new study design.
- Manages the timelines and quality for all statistical deliverables.
- Participates in study report preparation, summarizing statistical methodologies and results.
- Provides statistical supports for NDA/sNDA submissions.
- Participates in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions, as needed.
- Other Duties as assigned.
Requirements
Work Experience:
- At least 8 years of experience as a project statistician in a pharmaceutical or CRO environment.
- Preferably 5 years in Pharma and 3 years of experience supporting Oncology related work.
- 2 Years experiences with regulatory interactions and NDA submissions.
- 4 Years experience with SAS or other programming.
- Experience with CSR development.
- Experiences with all phases of clinical trials in Oncology preferred.
- Experience supporting publication related work.
- Expertise that is very applicable to the ongoing oncology related clinical trials. For example, the person is knowledgeable in relationship to QOL measures; non-inferiority analysis methods; Bayesian analyses and its applications in clinical trials; etc.
- Some management experience, in particular in terms of leading the process involved.
Functional/Technical Knowledge & Skills:
- Hands-on programming experience with SAS, S-Plus, or other related statistical software (Of these, the SAS programming experience is preferred).
- Experience having some regulatory agency related interactions (preferably in NDA submissions).
- Excellent analytical skills
Customer & Industry Knowledge:
- Knowledge of industry standard and regulatory requirements related to clinical design and statistical analysis.
- Knowledge of the drug development process.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
Education/Training:
- MS or equivalent in related fields.
Other Requirements:
- Excellent verbal and writing communication skills.
- Excellent interpersonal skills
- Ability to work in a fast paced and team-oriented environment.
To find out more about Real Staffing please visit www.realstaffing.com