Pionyr Immunotherapeutics Inc. is a well-funded and growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy. We are looking for a highly experienced and motivated Director, Biostatistics to work collaboratively with cross-functional teams to ensure appropriate study design, statistical analysis and reporting of clinical data to advance the company's mission of developing innovative therapies which empower the immune system to eradicate cancer.
Responsibilities include but not limited to:
- Work collaboratively with clinical development team in clinical study planning, study conduct, data analysis and reporting
- Serves as a Biostatistics Lead in strategically partnering with clinical development team on the planning, design, analysis, and reporting and communication of results (internally and externally) from clinical studies and preparation of regulatory submissions
- Ensures data and analysis quality - including the oversight of any external statistical vendors, contractors or consultants - when generating formal or informal tables, listings and figures
- Builds solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders
- Develops fit-for-purpose clinical trial designs, with decision-making operating characteristics, power, sample size and timeline considerations, as well as other development needs addressed via their statistical toolset
- Appropriately adopts or develops innovative statistical methods to solve scientific questions, support decision making, or guide product or process improvements
- Translates scientific questions into statistical terms and statistical concepts into layman terms
- Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
- Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project
- Keeps abreast of new developments in statistics, drug development and regulatory guidance and requirements through literature review and professional activities
- Responsible for writing statistical analysis plans and mockup TLFs for individual studies and ISS/ISE
- Support and participate in the preparation of study reports, regulatory submissions, and annual safety update reports.
- Review and provide statistical input on study documents (protocol, CRF, IB, DSUR, etc)
- Work with department heads and colleagues to develop, implement and maintain internal and outsourced biostatistics department standards and practices
- Collaborate with researchers and thought leaders in the planning of clinical development program and the publication of study data
- Perform and/or validate statistical analysis to support publication and conference presentation
- Be able to conduct independent research and resolve statistical methodological issues
- Perform ad hoc analysis and data validation as needed.
- Assist non-routine projects as applicable in support of clinical development activities
- PhD in biostatistics, statistics, mathematics or a related field. MS considered with appropriate additional experience
- Minimum 10 + years’ relevant experience within the biotechnology or pharmaceutical industry; Experience in immuno-oncology therapeutics a plus
- Sound understanding of theoretical and applied statistics
- Fluency with standard statistical software (SAS or R). R programming skills a plus.
- Demonstrated ability in providing statistical input and direction in clinical study designs, statistical approaches, interpretation of findings and crafting of key messages
- Knowledge of industry standards for clinical data collection and data base structure, e.g., CDISC guidelines for SDTM and ADaM data sets for both CRF and non-CRF data as well as experience with regulatory interactions (FDA or EMA)
- Ability to work independently and collaboratively on multiple projects, anticipate challenges and defend positions based on science and sound data analysis
- Ability to effectively communicate statistical concepts to non-statisticians
- Excellent analytical and problem-solving skills with a keen understanding of statistical principles and concepts.
- Statistical expertise in biomarker, and discovery data analysis methodologies.
- Advanced knowledge of the pharmaceutical industry, overall drug development process with expertise in cross-functional interactions with the statistics function.
- Experience in integrating real world evidence into drug development, and expertise in big data and machine learning techniques is a plus.
- Strong interpersonal, oral and written communication skills
- Ability to influence others and affect change across organizational boundaries.
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment. If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to firstname.lastname@example.org.