Head of Biostatistics
Reporting to the CMO, this person will be tasked with leading biostatistics & programming support across all Moderna clinical programs to ensure that projects are optimally strategized, correctly designed, properly analyzed and clearly presented to support new product development and domestic and international regulatory submissions. Drawing on comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics, this role will require strong communications and influencing skills in order to leverage internal and external resources to achieve high quality, timely and cost-effective study deliverables.
- Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts, and manuscripts to ensure that statistical elements are in line with the overall product strategy.
- Represent Biostatistics in meetings with cross-functional project teams and regulatory agencies. ensuring adherence to FDA/ICH guidelines, Good Clinical Practices, and regulatory requirements by contributing to SOP development and training;
- Lead the development and adaptation of new statistical methodology in support of drug research and development as required and keep current with regulatory guidance and requirements in the global environment.
- Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
- In development-phase projects, prepare the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
- Provide specifications and directions to the clinicians/statistical programmers. Partner in program design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
- Supervise statisticians on the team (as assigned) including settling of objectives, performance management and professional development of associates.
- Ensure that statistical expertise across is fully integrated into the project. Understand and contribute to project strategy. Plan, prioritize and track project level activities, including assess and allocate resources.
- Plan and manage submission activities, including SCS, SCE, RMP and Briefing Books. Interaction with Health Authorities and external consultants as appropriate.
- Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings.
- Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables.
- Work closely with data management, clinical operations, programming, and other biostatisticians across programs
- Provides input in preparation of study reports, with particular emphasis on the statistical methods section, and may work with Medical Writing in study report preparation.
- PhD degree in Statistics or Biostatistics with at least 10 years of relevant work experience in Phase I-III in diverse therapeutic areas such as vaccines, rare diseases, and oncology
- Comprehensive knowledge of statistical methodology in design and analysis, and regulatory requirements relating to clinical development of drugs and biologics.
- Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
- Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.
- eCTD BLA/NDA experience as well as past interaction with FDA and/or interaction with EMA/CPMP and preparation of MAA.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
- Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials.
- Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure, and in a team environment to meet established deadlines.
- Maintains current awareness of new drug developments in the business.
- Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.