To provide leadership of all aspects of Biostatistics for Geron’s clinical programs. Lead biostatistical research and support for all aspects of the imetelstat drug development programs which treat hematologic myeloid malignancies. To provide biostat support for preclinical studies and oversee biostat CROs and contractors using statistical software for analysis and reporting.
- Provide leadership for biostat function which supports all aspects of the imetelstat development programs in oncology that will be required to enable optimal study design, analysis and reporting.
- Provide strong technical, scientific, statistical and strategic drug development expertise as part of Geron’s clinical development team.
- Develop processes and standards that are in accordance with GCP and ICH guidelines to enable efficient and consistent biostat activities.
- Oversee and implement advanced statistical theories, methodologies and techniques which are required to enable optimal study design, analysis and reporting.
- Oversee CRO statisticians and researchers amassing data from oncological clinical trials to liaise the transmission of statistically accurate information about product quality, safety and efficacy to doctors and program directors.
- Contribute to adaptive nature of protocol development during clinical trials by revising study design, devising statistical methodologies and models, defining endpoints, calculating necessary sample sizes, and choosing statistical comparisons.
- Lead the clinical study report (CSR) development process by performing statistical analyses and preparing sections of the report on scientific presentations.
- Use statistical software such as SAS and/or R programming to analyze data from clinical studies, and real-world, and then generate or review and approve tables, listings, and graphs (TLGs).
- Use advanced design software such as PASS and EAST for complex and adaptive study design.
- Check, analyze and abide by critical regulatory standards under GCP and ICH guidelines to assure data integrity.
- Support drug regulatory submissions like NDA/BLA to the FDA and to ex-US regulatory authorities.
- Contribute to protocol development by choosing an appropriate study design and statistical methodology, defining endpoints, calculating necessary sample size, and writing statistical sections of the protocol.
- Develop or review statistical analysis plans and reports.
- Establish and negotiate accurate timelines with internal and external team members for completion of study-related biostatistical activities.
- Represent biostatistics on project teams.
- Be flexible and thoughtful about new statistical approaches and be able to communicate effectively with medical, clinical, and programming personnel.
- Conduct and participate in validation and quality control of project deliverables as necessary.
- Collaborates with internal and external resources (CRO's) to ensure consistency of methods, interpretation and approach.
Skills and Attributes
- PhD in Statistics/Biostatistics/related with at least 3 years of experience in biotech/pharma industry (as a Biostatistician, Senior Statistician, Principal Statistician, Statistician, or Associate Director/Researcher-Statistical), including
- Leading biostatistical support for imetelstat drug development programs which treat hematologic myeloid malignancies;Overseeing and implementing advanced statistical methodologies;
- Using statistical software to analyze data from clinical studies and real-world;
- Overseeing CRO statisticians, and liaising with program directors; and
- Supporting drug regulatory submissions, such as ICH and other regulatory requirements related to biostatistical activities.
- With any suitable combination of education, training or experience accepted.
- Later stage clinical trials, NDA/BLA submissions, and experiences with FDA and ex-US regulatory authorities are highly desired.
- Leadership capabilities, including an ability to appropriately prioritize and resource to drive for results, to deploy sound judgment in complex situations, to maintain a positive attitude in face of adversity, and to effectively influence and work with others at multiple levels within the organization.
- Excellent written and oral communication as well as strong interpersonal communication skills.
- Strong implementation skills.
- A record of commitment to the success of others and total ownership and accountability of personal and functional performance.
Please respond to: Stephanie Dellari, Executive Director, Human Resources, Geron Corporation, 919 E. Hillsdale Blvd. Suite 250, Foster City, CA 94404 or email@example.com Ref "DBiost”.
Geron is an equal opportunities employer with a strong emphasis on providing employees with a working environment in which they can succeed, excel, and be fulfilled.