Sr. Manager, Statistical Programming

Looking 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. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. 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. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.  

Hybrid

Employee Value Proposition: 

At Taiho Oncology, Inc., our compassion to advance research and development of innovative anti-cancer therapies extends to our team, empowering each team member to work with a shared purpose to improve the quality of life for oncology patients and their families. This is an exciting opportunity to join a diverse and highly talented team and be a part of making a meaningful difference in the lives of oncology patients.

Position 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 process 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 documentations.
• Identifies problems and develops global tools that increase the efficiency and capacity.
• Organizes or participates 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.
• Good writing skills.
• 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. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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