Principal Statistical Analyst

Overview of Role:

The Principal Statistical Analyst will be responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs. Produce, review program codes and suggest alternative solutions that may be efficient. Allocate resource for project, manage project timeline, control quality of deliverables and ensure compliance of procedure. Interact with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory.

Role and Responsibilities:

• Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs
• Consolidate heterogeneous data source (e.g. clinical study databases, external databases, real world data) to prepare analysis-ready datasets supporting a particular project, study deliverable
• Work closely with Biostatistician to implement CDISC SDTM and ADAM specification datasets
• Perform compliance check and resolve any compliance issue during the process
• Create documentation for regulatory filings including reviewers guides and data definition documents and ensure compliance per FDA guideline
• Perform data analysis, statistical analysis, generate safety and efficacy tables, figures and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/OD
• Review Data Management Plan, Data monitoring plan and edit check specification
• Implement data monitoring listings and SAS edit check to support team data monitoring
• Evaluate scope of work for project or ad hoc requests on resource allocation, timeline buildup, and become the stakeholder on delivery
• Validate work of other programmer/analysts at CRO or in-house to ensure appropriate validation process
• Create, debug, validate or maintain company level macros that streamline repetitive operations to increase programming efficiency
• Act as a liaison in study team between statistical programming, and other functional teams as needed
• Leads or participates in the development of standard operating procedures (SOP)
• Work on improving the efficiency and quality of existing workflows and mentors Statistical Programmers and Statistical analysts
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's or Master's degree in Biostatistics, statistics, computer science or related field
• Minimum 7+ years Pharmaceutical/Biotech programming experience. Experience working with Oncology trials preferred
• Solid knowledge on CDISC standards including (SDTM, ADaM)
• Good understanding and hands on experience on programming support for data monitoring and data clean/query process
• Good understanding on clinical data coding dictionaries (MedDRA and WHODD)
• High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development
• Working knowledge of current regulatory requirements and ICH guidance with deep understanding on clinical trial compliance requirements; Knowledge of Pinnacle 21
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA, NDA/BLA or other regulatory filling experience, including ISS or ISE experience
• The ability to work well under pressure and shifting priorities, both as a team leader and as a team member
• The ability to plan, execute and manage project resources, timeline, and delivery with good skill on setting priorities
• Ability to proactively identify and address project uncertainties to minimize risk
• Strong problem solving and analytical skills
• Fluency in 2 or more or relevant programming languages, such as R, Python will be plus
• Ability to communicate clearly both oral and written