Volt has partnered with a a clinical-stage biotechnology company developing first-in-class immunology therapeutic product candidates to patients, who is now hiring for a Biostatistician!
This is a direct hire opportunity, with competitive salary and benefits, located in San Diego!
Focusing on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, we develop our product candidates using our proprietary antibody discovery technology platform, which is based upon a breakthrough understanding of the natural process of antibody generation, known as somatic hypermutation, or SHM. This replicates th natural process of antibody generation in vitro. Our strategy is to advance the development of our proprietary product candidates, and where applicable, establish partnerships with leading biopharmaceutical companies where we retain certain development and commercialization rights.
The Senior Biostatistician/Biostatistician will participate in designing clinical studies, assist in protocol development, review study protocols, contribute to and review data management documents, oversee statistical analysis activities, create and/or review statistical analysis documents, SAPs, assist in CSR development and/or review CSR, contribute to Data Management Plans. This role may also participate supporting analysis of non-clinical / pre-clinical /CMC data when needed. Expected to work closely with Clinical Study Team members and with Dir, Data Management. Expected to direct and oversee statistical analysis deliverables from CROs.
- Demonstrate practical understanding and recognition of statistical concepts and methodologies appropriate for use in the pharmaceutical industry. Provide statistical support for design, analysis, and reporting of clinical, nonclinical or pharmacokinetic trials.
- Ensure internal consistency and assess consistency with other studies, if applicable, and provide certification for the protocol review check list. Develop statistical methods sections for routine studies and, with supervision, for non-routine studies, and ensure alignment with analyses as conducted.
- Contribute to decision making on study design and data collection, and, with supervision, ensure appropriateness to support study objectives. Work collaboratively with others to develop quality protocols, CRFs, databases, reports, and publications per agreed timelines.
- Responsible for sample size calculations for routine studies. Calculate sample size for non-routine studies with supervision.
- Determine statistical methods for routine studies, and ensure statistical methods adequately address study objectives. Able to apply statistical knowledge to solve drug development problems. Identify and recommend corrections for flaws in scientific logic and statistical interpretation.
- Contribute to statistical methodology for non-routine studies. Provide statistical insight into the development of report strategy and assist in ensuring consistency among reports within a project.
- Ensure clarity, accuracy and consistency of case report forms (CRFs), database definitions, and specifications for analysis data sets for individual studies. Develop statistical analysis plans (SAPs) for routine studies and, with supervision, for non-routine studies, ensure consistency.
- Provide accurate and timely responses to routine requests from clients and independently pursue analyses suggested by the data. Responsible for developing and maintaining good client relationships. Identify and report on data issues or violation of statistical assumptions that could affect the validity or sensitivity of planned analyses. Recommend alternative analysis strategies to address data issues or violation of statistical assumptions.
- Assist development of project conventions and verify project conventions are followed.
- Ensure accuracy of database quality assurance checks and assess data accuracy and consistency. Develop database checks for routine situations.
- Participates in the preparation of data review and regulatory submissions
- Writes or reviews key study documents to ensure optimal statistical presentation and compliance. These documents include, but are not limited to, protocols, analysis plans, tables, listings, and figure (TLF) specifications, study reports.
- Ensures efficient planning, execution and reporting of clinical studies and statistical review of critical documents such as CRFs, Data Validation Plans, CDISC, SDTM/ADaM data specifications, TLFs.
- Ensures statistical analyses performed in accordance with the protocol, statistical analysis plan, good statistical practice, and available regulatory guidelines.
- Developing Statistical Protocols: Effectively communicates with project manager to understand to objectives of the study. Follows the appropriate operating procedure required for developing the statistical plan. Demonstrates the ability to research and provide appropriate statistical input to the study design.
- Data Analysis: Write SAS code for common statistical analyses. Understands and correctly uses validated SAS macros in the data analysis programs. Understands program verification procedure; writes and executes program verification plans.
- Post-Analysis Activities: Participates in the creation of the verification plan and line listings. Prepares and reviews statistical sections contained in submissions and other publications. Prepares statistical summaries in a timely manner for team and management review.
- Provide in-depth statistical expertise in the areas of; experiment, protocol, case report form design, data base structure, and analysis plan; collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity.
Education & Experience
- Theoretical knowledge typically achieved through a related post-graduate college experience, such as a PhD degree in Statistics or a related field
- Five/Eight years of statistics experience in the pharmaceutical or related industry
Knowledge & Competencies
- Computational skills in SAS programming
- Excellent technical skills with MS Words, MS Excel, and MS Power Point
- Communicates an understanding of statistical concepts, basic clinical principles, and regulatory standards for the project, and act in accordance with those principles
- Possess experience in Statistical writing and data analysis both by design and ad hoc to support program plans/product validation
- Must have excellent people skills and demonstrate the ability to work successfully in a team environment.
- Ability to prioritize and to manage multiple tasks as necessary.
- Ability to work in a team as well as independently, and to manage multiple priorities with minimal support in a fast pace environment
- High customer orientation awareness and focus
- High degree of technical competence and communication ability, both oral and written
Volt is an equal opportunity employer