Overview

Utilize personal experience and technical expertise to support the Clinical Analytics team as we analyze, interpret, and present clinical and non-clinical data to stakeholders.  Plan and lead the development of statistical solutions, analyses in SAS or comparable statistical software, and support data management.  Support legacy studies and make contributions to new clinical studies that build evidence supporting the therapy.

Responsibilities

• Initiate, plan, execute and manage all aspects of data analysis/management including, but not limited to:

• Case report form design, define/program database/edit check specifications
• Creation and maintenance of databases
• Draft and review Statistical Analysis Plans (SAPs)
• Develop SAS solutions for analysis of clinical data. (Sample size determination, appropriate statistical methodology, etc)
• Assist in statistic model selection, experimental design, design and analysis of clinical trials
• Collaborate with database developers on the design, documentation, testing and implementation of study database based on data management and protocol requirements.
• Provide data cleaning support
• Assist in statistical validation in accordance with regulatory standards and procedures
• Assist in integration and transfer of databases as needed
• Identify risks & provide mitigation plans for data management related deliverables
• Track study progress to anticipate reporting needs in coordination with clinical team
• Provide deliverables (tables/listings/graphs and interpretations)
• Lead in the review and development of tables, listings, and figures as specified in the Statistical Analysis Plan.

• Lead with the creation of ad hoc analyses and summaries as requested.
• Involved in the QC of all the deliverables created by programming and statistics (e.g. output, the statistical section in the study report).
• Build successful relationships and seamless interfaces at the protocol / project team level, and provide timely and effective communication to the study team / trial manager and functional leads.
• Provide input for the technical infrastructure of the biostatistics function.
• Develop and implement strategy for the improvement of productivity and standardizing of biostatistical activities.
• Lead in developing, applying and promoting consistent standards through standard processes and SOPs.
• Collaborate with cross functional teams including R&D, Quality, and Regulatory for relevant analyses

• Present results in a clear, concise manner to cross functional peers and management.
• Lead and participate in deep dive data discussions and provide analytical strategy for management, KOL’s and other key stakeholders
• Defines and understands the data review requirements and processes to ensure delivery of high quality data

• Maintains a broad understanding of relevant clinical disease state and trends/directions of data management and analysis

• Assists with developing and building analytical / database expertise within the team
• Provides technical expertise for developing and implementing new technologies or software
• Collaborates with study teams to bring innovative solutions to the clinical analytics team
• Able to take independent action to initiate process improvement, when needed.

Qualifications

• MS Degree in the Biostatistics discipline with a minimum of 3 years of experience in the device / pharma industry.
• Experience with SAS 9 (SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/ODS), MS Office, and computer skills
• Coding dictionary experience preferred.
• Strong communication skills, both verbal and written.
• Strong scientific background and understanding of clinical trials, pharmaceutical / device operations, and regulatory compliance.
• Practical knowledge of ICH, FDA, and GCP regulations and guidelines.
• Proven ability to take independent action to initiate process improvement, when needed.
• Proven ability to deliver on delegated work efficiently.