Alnylam Pharmaceuticals
Associate Director, Biostatistics
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
The Associate Director, Biostatistics
is responsible for statistical activities in support ofclinical trials, including contributing to trial designs, authoring statistical sections of protocols,preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trialdata.
Summary of Key ResponsibilitiesRepresents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.Contributes to or prepares statistical analysis plans.Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.Provides statistical guidance on conduct of ongoing trials.Collaborates with Statistical Programmers on summary and analysis of trial data.Writes ADS and ad hoc analysis specifications.Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, andother stakeholdersContributes to scientific articles, summarizing data collected in Alnylam trials.Participates in other activities and meetings to support Biostatistics and theDevelopment Team as needed.Consults with Research & Preclinical colleagues on statistical questions in their work.Manages CRO statistical and programming support.QualificationsPh.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience.Excellent written and oral communication and presentation skills.Experience programming in SAS.Interest in and basic understanding of biology and biological processes, including RNAi.Desired Experience:Experience in clinical development through Phase 3 (NDA submission).Experience as lead statistician for a compoundUnderstanding of ICH GCP as well as general knowledge of industry practices and standards.Proficiency in R programming language and other statistical software, including EAST.Experience with CDISC, including SDTM, ADaM, CDASH.Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.Experience designing and conducting adaptive trials.Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching
work environment.About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.>#J-18808-Ljbffr
is responsible for statistical activities in support ofclinical trials, including contributing to trial designs, authoring statistical sections of protocols,preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trialdata.
Summary of Key ResponsibilitiesRepresents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.Contributes to or prepares statistical analysis plans.Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs.Provides statistical guidance on conduct of ongoing trials.Collaborates with Statistical Programmers on summary and analysis of trial data.Writes ADS and ad hoc analysis specifications.Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, andother stakeholdersContributes to scientific articles, summarizing data collected in Alnylam trials.Participates in other activities and meetings to support Biostatistics and theDevelopment Team as needed.Consults with Research & Preclinical colleagues on statistical questions in their work.Manages CRO statistical and programming support.QualificationsPh.D. in Biostatistics or Statistics or Equivalent with at least 7 years pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience.Excellent written and oral communication and presentation skills.Experience programming in SAS.Interest in and basic understanding of biology and biological processes, including RNAi.Desired Experience:Experience in clinical development through Phase 3 (NDA submission).Experience as lead statistician for a compoundUnderstanding of ICH GCP as well as general knowledge of industry practices and standards.Proficiency in R programming language and other statistical software, including EAST.Experience with CDISC, including SDTM, ADaM, CDASH.Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.Experience designing and conducting adaptive trials.Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching
work environment.About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.>#J-18808-Ljbffr