Wave Life Sciences
Job Description
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation, and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference, and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency, and Huntington's disease, as well as a preclinical program in obesity. Driven by the calling to "Reimagine Possible," we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description
The Director, Biostatistics, will be responsible for providing statistical leadership and support for clinical studies that investigate the safety and efficacy of Wave compounds at the clinical stage of development (including Phase 1, Phase 2, or Phase 3). Reporting to the Head of Biometrics, the successful candidate will provide strategic, statistical, and operational leadership to support successful advancement of clinical programs. Responsibilities include collaborating on clinical trial designs, authoring SAPs, working with the programming team, and supporting data review processes. The candidate should be interested in applying innovative statistical and machine learning methods to support Wave’s mission of delivering life-changing medicines for patients with genetic diseases. Experience
8+ years as a biostatistician in biotech/pharmaceutical companies with a PhD in Statistics, Biostatistics, or a related field; or 12+ years with an MS degree in the same fields. Responsibilities
Provide expertise in clinical study design, including sample size calculations and statistical sections for protocols. Collaborate with multi-disciplinary teams on trial implementation, including eCRF design and randomization. Apply statistical and machine learning methodologies, keeping abreast of regulatory guidance, especially for rare diseases. Author and review SAPs, ensuring timely finalization to support study readouts. Develop tables, listings, and figures for study reports and regulatory submissions. Review DSMB charters and support the creation of CDISC-compliant datasets. Ensure proper blinding and data confidentiality protocols are followed. Interpret study results, support CSR development, and contribute to publications. Coordinate with external vendors and internal teams to ensure quality and timeliness of deliverables. Provide oversight and guidance to external contractors. Communicate effectively with team members and senior management. Key Skills
Deep knowledge of statistical and machine learning methods in clinical trial contexts. Excellent communication skills, capable of explaining complex methods to non-statisticians. Proficiency in SAS, R, and Python for data analysis and simulations. Organized, detail-oriented, adaptable, and a team player. Knowledge of regulatory guidelines for drug development, especially in rare diseases. Wave Life Sciences provides equal employment opportunities and prohibits workplace harassment. We value relationships with recruitment firms but do not accept unsolicited resumes without a formal agreement.
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The Director, Biostatistics, will be responsible for providing statistical leadership and support for clinical studies that investigate the safety and efficacy of Wave compounds at the clinical stage of development (including Phase 1, Phase 2, or Phase 3). Reporting to the Head of Biometrics, the successful candidate will provide strategic, statistical, and operational leadership to support successful advancement of clinical programs. Responsibilities include collaborating on clinical trial designs, authoring SAPs, working with the programming team, and supporting data review processes. The candidate should be interested in applying innovative statistical and machine learning methods to support Wave’s mission of delivering life-changing medicines for patients with genetic diseases. Experience
8+ years as a biostatistician in biotech/pharmaceutical companies with a PhD in Statistics, Biostatistics, or a related field; or 12+ years with an MS degree in the same fields. Responsibilities
Provide expertise in clinical study design, including sample size calculations and statistical sections for protocols. Collaborate with multi-disciplinary teams on trial implementation, including eCRF design and randomization. Apply statistical and machine learning methodologies, keeping abreast of regulatory guidance, especially for rare diseases. Author and review SAPs, ensuring timely finalization to support study readouts. Develop tables, listings, and figures for study reports and regulatory submissions. Review DSMB charters and support the creation of CDISC-compliant datasets. Ensure proper blinding and data confidentiality protocols are followed. Interpret study results, support CSR development, and contribute to publications. Coordinate with external vendors and internal teams to ensure quality and timeliness of deliverables. Provide oversight and guidance to external contractors. Communicate effectively with team members and senior management. Key Skills
Deep knowledge of statistical and machine learning methods in clinical trial contexts. Excellent communication skills, capable of explaining complex methods to non-statisticians. Proficiency in SAS, R, and Python for data analysis and simulations. Organized, detail-oriented, adaptable, and a team player. Knowledge of regulatory guidelines for drug development, especially in rare diseases. Wave Life Sciences provides equal employment opportunities and prohibits workplace harassment. We value relationships with recruitment firms but do not accept unsolicited resumes without a formal agreement.
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