What are the responsibilities and job description for the Principal Statistical Analyst position at Summit Therapeutics?
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 :
The pay range for this role is $170,000-$190,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and / or other applicable variable compensation.
Summit does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact Summit's Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
Salary : $170,000 - $190,000
