Daiichi Sankyo
Manager, Statistical Programming - Pharmacometrics
Daiichi Sankyo, Atlanta, Georgia, United States, 30383
Manager, Pharmacometric ProgrammingJoin a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The Manager, Statistical Programming – Pharmacometrics will use diverse and innovative programming tools to integrate data from different sources to enable pharmacometrics analyses that are incorporated into regulatory filings and used for internal clinical development decision making. The individual will prepare integrated analysis data sets for use by quantitative clinical pharmacology (QCP) modeling experts, and produce tables, listings, and figures, and assist in the preparation of pharmacometric reports and electronic submission datasets with the support of other subject matter experts.
Responsibilities:Apply expert knowledge of SAS and other data programming tools to integrate clinical data across multiple studies for pharmacometrics analyses using NONMEM and other modeling tools
Implement sophisticated algorithms to derive complex data sets, and address emerging data integration challenges
Assist with preparation of tables, listings, and figures for pharmacometric reports to be included in regulatory submissions
Contribute to optimization of pharmacometrics analysis workflows, with particular focus on delivery of integrated datasets and analysis reports
Develop streamlined data integration workflows
Collaborate with scientists in QCP to coordinate integration of data from multiple studies, and plan dataset delivery and reporting
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:Bachelor's Degree engineering, science, computer science, mathematics, statistics, informatics, data sciences, or related field required
Master's Degree engineering, science, computer science, mathematics, statistics, informatics, data sciences, or related field preferred
Experience:1 or more years' experience with the following systems required: SAS, R, and/or Python
1 or more years' experience with SAS programming language used in clinical trials programming required
1 or more years working knowledge of CDISC, SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis required
1 or more years' experience with principles of quality control and the validation of computer programs required
1 or more years' experience preparing SAS datasets for clinical trial reporting preferred
4 or more years industry experience with B.S. required or 1 or more years industry experience with M.S. required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary:
The Manager, Statistical Programming – Pharmacometrics will use diverse and innovative programming tools to integrate data from different sources to enable pharmacometrics analyses that are incorporated into regulatory filings and used for internal clinical development decision making. The individual will prepare integrated analysis data sets for use by quantitative clinical pharmacology (QCP) modeling experts, and produce tables, listings, and figures, and assist in the preparation of pharmacometric reports and electronic submission datasets with the support of other subject matter experts.
Responsibilities:Apply expert knowledge of SAS and other data programming tools to integrate clinical data across multiple studies for pharmacometrics analyses using NONMEM and other modeling tools
Implement sophisticated algorithms to derive complex data sets, and address emerging data integration challenges
Assist with preparation of tables, listings, and figures for pharmacometric reports to be included in regulatory submissions
Contribute to optimization of pharmacometrics analysis workflows, with particular focus on delivery of integrated datasets and analysis reports
Develop streamlined data integration workflows
Collaborate with scientists in QCP to coordinate integration of data from multiple studies, and plan dataset delivery and reporting
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education:Bachelor's Degree engineering, science, computer science, mathematics, statistics, informatics, data sciences, or related field required
Master's Degree engineering, science, computer science, mathematics, statistics, informatics, data sciences, or related field preferred
Experience:1 or more years' experience with the following systems required: SAS, R, and/or Python
1 or more years' experience with SAS programming language used in clinical trials programming required
1 or more years working knowledge of CDISC, SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis required
1 or more years' experience with principles of quality control and the validation of computer programs required
1 or more years' experience preparing SAS datasets for clinical trial reporting preferred
4 or more years industry experience with B.S. required or 1 or more years industry experience with M.S. required
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.