Contact: Neisha Camacho/Terra Parsons
Responsible for providing statistical support of sponsor studies and lending your statistical expertise and leadership.
Provide statistical expertise for experimental design, descriptive and inferential statistics, and analysis and reporting of clinical research studies
Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety data and for benefit-risk analyses
Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP).
Works collaboratively with multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific/statistical issues that may arise, in a timely manner
Provides responses to routine questions, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data.
Communicates a basic understanding of scientific principles for assigned projects and acts in accordance with those principles. Clearly communicate fundamental statistical concepts to other statisticians, scientists, and other personnel.
Participates in departmental activities including training/mentoring, research efforts, and cross-functional collaborations, as necessary
High degree of technical competence and sound communication ability, both oral and written
Identifies data or analytical issues and either applies skills and knowledge to solve problems or seeks help to achieve solutions
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Learns fast, grasps the 'essence' and can change the course quickly where indicated
Reviews case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
Participate in the development and subsequent utilization of statistical tools for conducting meta-analyses of safety data and for benefit-risk analyses.
Authors or oversees authorship of Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs). Ensure rigorous approaches are taken to ensure good scientific practices as followed: proper statistical methods utilized in analysis plans, and assay methods are appropriately designed, blinded, and randomized to meet objectives.
Provides statistical guidance/oversight to statisticians regarding requirements and GCP standards.
Performs exploratory statistical analyses and quantifies the benefits, risks, values and uncertainties of drug research and development to make sound conclusions and propose drug development strategies.
Makes statistical contributions to clinical study reports, including authoring of statistical methods, data interpretation Clinical Study Reports (CSRs), and manuscripts for publication/presentation.
Accounts for statistical activities in support of IND/NDA or other regulatory submissions. Address statistical questions/comments from FDA and other regulatory agencies, and review and address comments by IRB/ECs.
Solid well-grounded experience in oversight / management of biostatistical, programming, and data management services.
Demonstrates extensive experience in statistical data analysis of clinical trials (Phase 1-3) as well as integrated data analyses of safety and efficacy.
Experience in statistical programming (SAS and R) and other relevant statistical analysis software systems.
Extensive experience in regulatory authority interactions and submissions.
Responsible for developing and maintaining good client relationships
Other duties as assigned
MS in Statistics, Biostatistics or a highly related field. At least 7+ years experience
PhD in Statistics, Biostatistics or a highly related field. At least 5 + years experience
Strong desire to learn and develop new skills
Previous experience within the pharmaceutical industry highly preferred
Strong communication (both written and verbal) and presentation skills
Proven ability to develop deep working relationships
Effective time management and organization skills to succeed in fast-paced environment
Efficiency with Microsoft Office (Outlook, Word, Excel, and PowerPoint) & CRM systems