Associate Director, Biostatistics
About The Position
About Summit Ivonescimab known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinibHARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expressionIvonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role Serves as the study level biostatistician including reviewing protocol conducting sample size calculations developing statistical analysis plan data presentation plan and Data Monitoring Committee DMC charter reviewing study documents eg CRFs ADaM specifications statistical outputs etc for clinical trials in oncology Partners with cross functional team members in ensuring accuracyconsistency of clinical data and exceptional delivery interpretation of clinical results and assists in the development and review of regulatory submission documents Implements biostatistics department policies standards procedures and work instructions
Requirements
- PhD in Statistics Biostatistics or equivalent area with 6 years biopharmaceutical industry experience required MS degree in related discipline with extensive industry and leadership experience 8 years can be considered
- Strong proficiencies in software and other tools typically used by Biostatistics eg SAS R
- Good understanding of clinical trial processes and statistical programming requirements
- Working knowledge of ICH FDA and GCP regulations and guidelines
- Attention to detail accuracy and confidentiality
- Clear and concise oral and written communication skills
- Must be able to effectively multi task and manage time sensitive and highly confidential documents
- Communicate effectively and articulate complex ideas in an easily understandable way
- Work in a fast paced demanding and collaborative environment
Responsibilities
- Provide statistical support to clinical development through the conduct of clinical studies in oncology
- Conduct sample size calculations and develop statistical analysis plans SAPs data presentation plans and DMC charters
- Collaborate with clinical operations data management and CRO to develop and implement CRFs database design and the overall data quality plan
- Review study documents eg protocol vendor data transfer specifications ADaM specifications statistical outputs for clinical trials in oncology
- Review the accuracy of clinical data perform statistical analysis ensure the application of appropriate statistical methods interpret study results and collaborate with clinical team and other team members to produce interim reports final clinical study reports
- Contribute to the preparation of manuscripts for publication ensuring accurate statistical reporting of research findings
- Develop and implement new statistical methodologies that enhance study design and analysis
- Reviews and analyzes safety reporting biomarker analyses and other aspects of clinical trial monitoring
- Independently defines required resources for assigned work seeking advice as needed
- Work with department leader to develop and implement department policies standards and procedures
- Adheres to regulatory requirements of study conduct statistical analysis principles industry standards and company SOPs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Education Level
Ph.D. or professional degree
