Rapport Therapeutics
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Director/Sr. Director, Biostatistics
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Rapport Therapeutics Rapport Therapeutics is driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. The company's innovative scientific platform is centered on Receptor Associate Proteins (RAPs), which play a crucial role in regulating receptor assembly and function. Your Impact Rapport is seeking a Director or Senior Director of Biostatistics who will have a pivotal role in shaping the design, analysis, and interpretation of clinical trial data for precision neuromedicine programs. The successful candidate will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process. Your Day-to-Day
Contribute to the design of clinical trials, including writing or reviewing statistical sections of protocols and statistical analysis plans (SAPs). Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards. Support the generation of tables, listings, and figures (TLFs) and contribute to the interpretation of results. Collaborate with Clinical and Regulatory teams to provide statistical input to study reports, regulatory submissions, and publications. Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA). Assist in the development, validation, and documentation of statistical methodologies and processes. Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables. Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making. Ensure all statistical activities comply with regulatory guidelines and company policies. Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs). Contribute to development of internal statistical processes, SOPs, and initiatives. Must-Haves
PhD with 10+ years of experience (12+ for Senior Director) OR MS with 12+ years of experience (15+ for Senior Director) in statistics, biostatistics, or a closely related discipline within the pharmaceutical or bio-tech sector. CNS therapeutic area experience is a plus. Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation. Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH). Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting. Ability to communicate complex statistical concepts clearly to non-statistical audiences. Strong attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced environment. Proven collaboration, leadership, and organizational skills. Significant experience with global regulatory agency interactions. Experience in resource planning, recruiting, and defining organizational needs with senior leaders. What Makes Rapport Special
Every role has meaning. The company is determined to discover a better way for patients, and employees will feel the passion from the start. Rapport is driven to innovate. The company's exciting science pushes boundaries and opens new possibilities. Your perspective matters. Employees are encouraged to share their ideas and work as a team. The company has a fun work environment. Rapport hires smart, dedicated, down-to-earth people that employees will enjoy spending time with. Leadership that cares – about employees, their growth, and development. The company offers a competitive benefits package, including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more. Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Director/Sr. Director, Biostatistics
role at
Rapport Therapeutics Rapport Therapeutics is driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. The company's innovative scientific platform is centered on Receptor Associate Proteins (RAPs), which play a crucial role in regulating receptor assembly and function. Your Impact Rapport is seeking a Director or Senior Director of Biostatistics who will have a pivotal role in shaping the design, analysis, and interpretation of clinical trial data for precision neuromedicine programs. The successful candidate will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process. Your Day-to-Day
Contribute to the design of clinical trials, including writing or reviewing statistical sections of protocols and statistical analysis plans (SAPs). Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards. Support the generation of tables, listings, and figures (TLFs) and contribute to the interpretation of results. Collaborate with Clinical and Regulatory teams to provide statistical input to study reports, regulatory submissions, and publications. Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA). Assist in the development, validation, and documentation of statistical methodologies and processes. Oversee and manage external CROs and vendors to ensure high-quality and timely deliverables. Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making. Ensure all statistical activities comply with regulatory guidelines and company policies. Assist in the preparation of regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDAs). Contribute to development of internal statistical processes, SOPs, and initiatives. Must-Haves
PhD with 10+ years of experience (12+ for Senior Director) OR MS with 12+ years of experience (15+ for Senior Director) in statistics, biostatistics, or a closely related discipline within the pharmaceutical or bio-tech sector. CNS therapeutic area experience is a plus. Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation. Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH). Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting. Ability to communicate complex statistical concepts clearly to non-statistical audiences. Strong attention to detail, organizational skills, and ability to manage multiple projects in a fast-paced environment. Proven collaboration, leadership, and organizational skills. Significant experience with global regulatory agency interactions. Experience in resource planning, recruiting, and defining organizational needs with senior leaders. What Makes Rapport Special
Every role has meaning. The company is determined to discover a better way for patients, and employees will feel the passion from the start. Rapport is driven to innovate. The company's exciting science pushes boundaries and opens new possibilities. Your perspective matters. Employees are encouraged to share their ideas and work as a team. The company has a fun work environment. Rapport hires smart, dedicated, down-to-earth people that employees will enjoy spending time with. Leadership that cares – about employees, their growth, and development. The company offers a competitive benefits package, including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more. Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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