Senior Manager, Statistical ScienceLocation Brisbane, California Workstyle Hybrid Apply
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
As a Statistical Science Study Lead, the Senior Manager is responsible for leading and managing all Statistical Science-related activities for one or more studies of a comprehensive gene therapy program to ensure high-quality deliverables are executed in line with agreed timelines.
- Provide statistical leadership, as a member of cross-functional study team, during protocol development (study design, sample size justification, and safety/efficacy analysis methods) and throughout study duration
- Collaborate with key stakeholders on study design and develop statistical analysis plan
- Analyze and validate data to support study deliverables, including filings, reports, publications, and presentations.
- Provide leadership and oversight for all Data Science deliverables for the study
* Note: This job can be hybrid, remote, or onsite in Brisbane location
For an assigned study, the Statistical Science Study Lead will perform a range of the following responsibilities:
- Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team (SART) according to team charters to ensure appropriate cross-functional collaboration, communication, and expert input into program deliverables and outcomes
- Communicate Statistical Science and/or Data Science guidance as a representative or lead representative in cross-functional study teams (e.g., Study Execution Team)
Statistical Science Deliverable Development and Execution
- Lead, and collaborate with others in Data Science, in the development of the statistical analysis plan (SAP) for the study including endpoint definition, sample size justification and statistical methodology; lead the execution of statistical analysis activities as outlined in the SAP and the related quality review and approval of deliverables
- Collaborate with others in Data Science and cross-functional stakeholders on study design
- Develop, and/or contribute to the development of, the following study-related deliverables: appropriate sections of study protocols, case report forms, data quality review and analyses, manuscripts, and sections of clinical study reports
- Contribute to and negotiate study timeline with cross-functional team; identify Statistical Science study resource needs to meet timeline
- Provide statistics area expertise to study team activities and deliverables
- Serve as the statistical expert for the study throughout the study lifecycle and ensure accuracy and reliability of statistical results for the entire study
- Work with cross-functional study team members (SET), other key stakeholders, and statisticians to analyze and interpret clinical study data
- Identify and manage issues and risks and escalate, as appropriate
- Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the program
- Understand and follow Statistical Science processes for study execution for all Statistical Science-related study deliverables
- Develop SOPs, WIs, guidelines, and templates
Clinical Development Focus
- Lead or support activities to prepare for meetings with regulatory agencies, including oral/written responses to agency questions, as needed
- Provide statistical leadership for preparation of marketing applications (e.g., NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies and other regulatory submissions (such as IND safety update, PSUR)
- Ensure the quality of data and accuracy of analyses in regulatory interactions (e.g. submissions) or publications
Subject Matter Expertise
The Senior Manager will be a subject matter expert. This position will contribute to and make an impact on the department and the cross-functional process.
- PhD degree preferred, or MS in statistics, biostatistics or related discipline
- 3+ years clinical trial experience in pharmaceutical and/or biotech company with PhD; 6+ years with MS
- Must have worked on statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports), electronic NDA and/or BLA submissions via eCTD, IND, CTA, or HTA interactions
- Strong programming skills in SAS, R, and other statistical software packages
In the U.S., the salary range for this position is $ 151,000 to $ 226,400 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.