Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
As the centralized engine for innovation & development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
Position Title: Director/Senior Director, Biostatistics
Position Location: New York, NY (location arrangements are flexible, however)
Manager Title: Head of Biometrics
The Director/Senior Director, Biostatistics provides statistical collaboration within Roivant R&D & investment team on evaluating in-house/in-licensing business development opportunities as well as clinical development projects. This person leads biostatistics strategic & operational activities for clinical development projects & assists in the development & implementation of departmental scientific policies & operational guidelines. This person will report to VP, Biometrics & Data Management. This position is a remote, work from home opportunity.
- Propose & critically evaluate asset development plan for either BD opportunity or internal development project via scenario analyses, statistical trial simulation & meta-analyses of appropriate historical data, regulatory precedence, & disease specific guidance.
- Ensure project teams have high-quality statistical support for creation of clinical development plans (CDP), study protocols, & operational details.
- Collaborate with clinical operations, clinical development to ensure development of high quality study protocol & efficient execution of clinical studies.
- Collaborate with data management, statistical programming to ensure data collection, programming specification are consistent with study objectives & planned analyses.
- Lead all aspects of statistical reporting & ensure compliance with data submission guidelines, including review and/or authoring of study documents, such as CRF, SAP, Top Line Results, CSR.
- Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, & in compliance with Good Clinical Practices.
- Promote & lead quantitative decision science to enable objective internal decision making process.
- Lead development of biostatistical processes focusing on efficiency & quality, while maintaining or exceeding industry best practices.
- Identify improvement opportunities, establish strategy & provide direction for team to develop solutions.
- Possess deep understanding of regulatory guidelines, drug discovery & development process, regionally & globally.
Skills, Qualifications, & Requirements:
- Ph.D. in Statistics or biostatistics with at least 10 - 13 years of experience in the biotechnology, pharmaceutical industry. Exceptional MS/MA candidate will also be considered.
- Deep understanding of statistical designs & methods for early & late development programs.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, & statistical practice.
- Experience in applying quantitative decision making methods to support internal Go/No-Go decision.
- Significant prior experience interaction with health authority agencies such as FDA & EMEA.
- Demonstrated track record of successful project management (6+ years) & evidence of leading role as biostatistician in progressing assets from early development to marketing applications.
- Outstanding ability & skills to effectively represent Biometrics & Data Management in interaction with senior management or cross-functional teams.
- Excellent verbal & written communication, & presentation skills.
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt, PASS & Nquery)
- Expert R programming skills a major plus.