Summittherapeutics
Principal Statistical Analyst
Summittherapeutics, Menlo Park, California, United States, 94029
Job Title: Principal Statistical Analyst
Department: Data Programming
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, and visualization on all Summit drugs. The role includes producing and reviewing program codes, suggesting alternative solutions, allocating resources for projects, managing project timelines, controlling the quality of deliverables, and ensuring compliance with procedures. Interaction with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory is essential. Role and Responsibilities: Work closely with Biostatistics to implement statistical analysis of clinical trial data, including 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 sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready datasets supporting a particular project or study deliverable. Collaborate with Biostatisticians to implement CDISC SDTM and ADaM specification datasets. Perform compliance checks and resolve any compliance issues during the process. Create documentation for regulatory filings including reviewers' guides and data definition documents, ensuring compliance with FDA guidelines. Conduct data analysis and statistical analysis, generating safety and efficacy tables, figures, and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/OD. Review Data Management Plans, Data Monitoring Plans, and edit check specifications. Implement data monitoring listings and SAS edit checks to support team data monitoring. Evaluate the scope of work for projects or ad hoc requests regarding resource allocation and timeline buildup. Validate the work of other programmers/analysts at CRO or in-house to ensure appropriate validation processes. Create, debug, validate, or maintain company-level macros that streamline repetitive operations to increase programming efficiency. Act as a liaison in study teams between statistical programming and other functional teams as needed. Lead or participate in the development of standard operating procedures (SOPs). Work on improving the efficiency and quality of existing workflows and mentor Statistical Programmers and Statistical Analysts. Perform all other duties as assigned. Experience, Education and Specialized Knowledge and Skills: Bachelor’s or Master’s degree in Biostatistics, Statistics, Computer Science, or a related field. Minimum of 7+ years of Pharmaceutical/Biotech programming experience, with experience in Oncology trials preferred. Solid knowledge of CDISC standards (SDTM, ADaM). Good understanding and hands-on experience in programming support for data monitoring and data cleaning/query processes. Good understanding of 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 a deep understanding of 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 filing 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, timelines, and delivery with good skills in setting priorities. Ability to proactively identify and address project uncertainties to minimize risk. Strong problem-solving and analytical skills. Fluency in 2 or more relevant programming languages, such as R or Python, is a plus. Ability to communicate clearly, both orally and in writing. The pay range for this role is $170,000-$190,000 annually. Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. This may differ in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonuses, stock, benefits, and/or other applicable variable compensation.
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Department: Data Programming
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, and visualization on all Summit drugs. The role includes producing and reviewing program codes, suggesting alternative solutions, allocating resources for projects, managing project timelines, controlling the quality of deliverables, and ensuring compliance with procedures. Interaction with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory is essential. Role and Responsibilities: Work closely with Biostatistics to implement statistical analysis of clinical trial data, including 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 sources (e.g. clinical study databases, external databases, real-world data) to prepare analysis-ready datasets supporting a particular project or study deliverable. Collaborate with Biostatisticians to implement CDISC SDTM and ADaM specification datasets. Perform compliance checks and resolve any compliance issues during the process. Create documentation for regulatory filings including reviewers' guides and data definition documents, ensuring compliance with FDA guidelines. Conduct data analysis and statistical analysis, generating safety and efficacy tables, figures, and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/OD. Review Data Management Plans, Data Monitoring Plans, and edit check specifications. Implement data monitoring listings and SAS edit checks to support team data monitoring. Evaluate the scope of work for projects or ad hoc requests regarding resource allocation and timeline buildup. Validate the work of other programmers/analysts at CRO or in-house to ensure appropriate validation processes. Create, debug, validate, or maintain company-level macros that streamline repetitive operations to increase programming efficiency. Act as a liaison in study teams between statistical programming and other functional teams as needed. Lead or participate in the development of standard operating procedures (SOPs). Work on improving the efficiency and quality of existing workflows and mentor Statistical Programmers and Statistical Analysts. Perform all other duties as assigned. Experience, Education and Specialized Knowledge and Skills: Bachelor’s or Master’s degree in Biostatistics, Statistics, Computer Science, or a related field. Minimum of 7+ years of Pharmaceutical/Biotech programming experience, with experience in Oncology trials preferred. Solid knowledge of CDISC standards (SDTM, ADaM). Good understanding and hands-on experience in programming support for data monitoring and data cleaning/query processes. Good understanding of 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 a deep understanding of 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 filing 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, timelines, and delivery with good skills in setting priorities. Ability to proactively identify and address project uncertainties to minimize risk. Strong problem-solving and analytical skills. Fluency in 2 or more relevant programming languages, such as R or Python, is a plus. Ability to communicate clearly, both orally and in writing. The pay range for this role is $170,000-$190,000 annually. Actual compensation packages are based on several factors unique to each candidate, including skill set, depth of experience, certifications, and specific work location. This may differ in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonuses, stock, benefits, and/or other applicable variable compensation.
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