Taiho Oncology, Inc.
Sr. Manager, Statistical Programming
Taiho Oncology, Inc., Princeton, New Jersey, us, 08543
Pleasanton, CA, USA ● Princeton, NJ, USA
Req #402Monday, November 11, 2024Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. We invite you to join us.HybridPosition Summary:The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, managing collaborations with CROs, and implementing quality control processes to ensure the integrity of statistical outputs.Performance Objectives:Effectively designs/develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PBRER, etc.Develops/validates statistical regulatory submission package (CDISC, SDTM, ADaM, define document, reviewer guide etc.); Acts as an SME in regulatory filings in terms of submission data package.Supervises and manages CROs and resources to ensure the delivery of high-quality TLFs and meeting project timelines.Develops SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required.Keeps management current on project status and provides ongoing risk assessments.Responsible for maintaining/archiving clinical database, SAS programs and results, and documentation.Identifies problems and develops global tools that increase efficiency and capacity.Organizes or participates in technical meetings including internal and external representatives.Education/Certification Requirements:Bachelor/Master's Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree).Knowledge, Skills, and Abilities:At least 9 years of relevant pharmaceutical industry work experience, including 3-year oncology experience.Experience in writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials.Experience with regulatory submission, creating all files, documents, and analyses necessary to support electronic submissions in eCTD format, including ISS/ISE.Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Experience with the CDISC SDTM and ADaM models and transforming raw data into these standards.Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry.Highly detail and quality oriented.A positive attitude, flexibility and a proactive thought process.Ability to effectively present information to management.Strong computer skills in industry standard statistical programming.The pay range for this position at commencement of employment is expected to be between $171,700 and $202,000 annually. This pay range is based on the market range for positions of this type.If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time.#LI-HybridEqual Opportunity Employer Information:
Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law.
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Req #402Monday, November 11, 2024Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. We invite you to join us.HybridPosition Summary:The position will be responsible for providing support and technical guidance of statistical programming to clinical project teams, managing collaborations with CROs, and implementing quality control processes to ensure the integrity of statistical outputs.Performance Objectives:Effectively designs/develops SAS programs for clinical study reports, for regulatory submission, and for IB updates, DSUR, PBRER, etc.Develops/validates statistical regulatory submission package (CDISC, SDTM, ADaM, define document, reviewer guide etc.); Acts as an SME in regulatory filings in terms of submission data package.Supervises and manages CROs and resources to ensure the delivery of high-quality TLFs and meeting project timelines.Develops SAS programs and performs quality control checks for SAS code and outputs produced by CROs as required.Keeps management current on project status and provides ongoing risk assessments.Responsible for maintaining/archiving clinical database, SAS programs and results, and documentation.Identifies problems and develops global tools that increase efficiency and capacity.Organizes or participates in technical meetings including internal and external representatives.Education/Certification Requirements:Bachelor/Master's Degree in Biostatistics, Mathematics, Statistics, Computer Science, Life Science (or equivalent degree).Knowledge, Skills, and Abilities:At least 9 years of relevant pharmaceutical industry work experience, including 3-year oncology experience.Experience in writing SAS programs to create data sets, tables, figures, and listings reporting results of clinical trials.Experience with regulatory submission, creating all files, documents, and analyses necessary to support electronic submissions in eCTD format, including ISS/ISE.Experience with SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH.Experience with the CDISC SDTM and ADaM models and transforming raw data into these standards.Experience working with all types of safety data and coding dictionaries commonly used by the pharmaceutical industry.Highly detail and quality oriented.A positive attitude, flexibility and a proactive thought process.Ability to effectively present information to management.Strong computer skills in industry standard statistical programming.The pay range for this position at commencement of employment is expected to be between $171,700 and $202,000 annually. This pay range is based on the market range for positions of this type.If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time.#LI-HybridEqual Opportunity Employer Information:
Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law.
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