Associate Director, Statistical Programming
Nuvalent, Inc., Cambridge, Massachusetts, us, 02140
Overview
The Company: Nuvalent, with deep expertise in chemistry, is working to create selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company that brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role
Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as outsourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations. This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs. Responsibilities
Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs. Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues. Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate. Partner with or oversee CROs or Programming vendors to perform the tasks described above. Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements. Manage project timelines and schedules of specific phases of projects and collaborate with internal personnel and outside customer representatives. Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications). Adaptability/Flexibility – the ability to adapt to working effectively within a variety of situations and to organizational changes and evolving job demands. Communication and Teamwork – the ability to express ideas clearly, work cooperatively, and contribute to team goals. Problem Solving – the ability to break down problems and identify patterns and connections. Relationship Building – builds productive working relationships and communicates across diverse groups. Organizational and results orientation – ability to plan and manage multiple responsibilities while maintaining quality and timeliness under pressure. Qualifications
Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field. 8+ years of SAS statistical programming experience in a clinical trial setting (industry/CRO). Advanced SAS programming skills (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH), including validation/QC and generating listings, tables, and figures. Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials. Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics, and data handling in clinical development, and knowledge of submission requirements and standards. Experience with outsourcing programming activities and overseeing CRO/contractor services. Advanced understanding of statistical concepts in support of clinical data analysis. Advanced knowledge of programming standards and processes. Oncology experience is required. Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers. Salary
Annual Salary Range: $180,000 — $210,000 USD EEO and Compliance
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, genetic characteristics or any other characteristic protected by applicable federal, state, or local law. Nuvalent is aware of fraudulent job postings and will not request personal or financial information via email. All legitimate correspondence from Nuvalent will come from @nuvalent.com email accounts, and legitimate job opportunities will be extended after a completed application and thorough interview process. If you believe you have been contacted by someone misrepresenting themselves as a Nuvalent employee, please contact Nuvalent at 857-357-7000. Thank you. Location
Cambridge, MA / Remote
#J-18808-Ljbffr
The Company: Nuvalent, with deep expertise in chemistry, is working to create selective medicines to address the needs of patients with cancer. Nuvalent is an exciting early-stage company that brings together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role
Reporting to the Senior Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as outsourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations. This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs. Responsibilities
Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs. Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues. Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate. Partner with or oversee CROs or Programming vendors to perform the tasks described above. Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements. Manage project timelines and schedules of specific phases of projects and collaborate with internal personnel and outside customer representatives. Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications). Adaptability/Flexibility – the ability to adapt to working effectively within a variety of situations and to organizational changes and evolving job demands. Communication and Teamwork – the ability to express ideas clearly, work cooperatively, and contribute to team goals. Problem Solving – the ability to break down problems and identify patterns and connections. Relationship Building – builds productive working relationships and communicates across diverse groups. Organizational and results orientation – ability to plan and manage multiple responsibilities while maintaining quality and timeliness under pressure. Qualifications
Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field. 8+ years of SAS statistical programming experience in a clinical trial setting (industry/CRO). Advanced SAS programming skills (Macro language, BASE SAS, SAS/STAT, SAS/GRAPH), including validation/QC and generating listings, tables, and figures. Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials. Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics, and data handling in clinical development, and knowledge of submission requirements and standards. Experience with outsourcing programming activities and overseeing CRO/contractor services. Advanced understanding of statistical concepts in support of clinical data analysis. Advanced knowledge of programming standards and processes. Oncology experience is required. Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers. Salary
Annual Salary Range: $180,000 — $210,000 USD EEO and Compliance
Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, genetic characteristics or any other characteristic protected by applicable federal, state, or local law. Nuvalent is aware of fraudulent job postings and will not request personal or financial information via email. All legitimate correspondence from Nuvalent will come from @nuvalent.com email accounts, and legitimate job opportunities will be extended after a completed application and thorough interview process. If you believe you have been contacted by someone misrepresenting themselves as a Nuvalent employee, please contact Nuvalent at 857-357-7000. Thank you. Location
Cambridge, MA / Remote
#J-18808-Ljbffr