Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
- 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