At Roivant, we are passionate about discovering and developing new drugs to impact patients' lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world's leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
The Director/Senior Director, Biostatistics provides statistical collaboration within Roivant R&D and investment team on evaluating in-house/in-licensing business development opportunities as well as clinical development projects. This person leads biostatistics strategic and operational activities for clinical development projects and assists in the development and implementation of departmental scientific policies and operational guidelines. This person will report to VP, Biometrics and Data Management. This position is a remote, work from home opportunity.
- Propose and critically evaluate asset development plan for either BD opportunity or internal development project via scenario analyses, statistical trial simulation and meta-analyses of appropriate historical data, regulatory precedence, and disease specific guidance.
- Ensure project teams have high-quality statistical support for creation of clinical development plans (CDP), study protocols, and operational details.
- Collaborate with clinical operations, clinical development to ensure development of high quality study protocol and efficient execution of clinical studies.
- Collaborate with data management, statistical programming to ensure data collection, programming specification are consistent with study objectives and planned analyses.
- Lead all aspects of statistical reporting and 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, and in compliance with Good Clinical Practices.
- Promote and lead quantitative decision science to enable objective internal decision making process.
- Lead development of biostatistical processes focusing on efficiency and quality, while maintaining or exceeding industry best practices.
- Identify improvement opportunities, establish strategy and provide direction for team to develop solutions.
- Possess deep understanding of regulatory guidelines, drug discovery and development process, regionally and globally.
Skills, Qualifications, and 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 and methods for early and late development programs.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and 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 and EMEA.
- Demonstrated track record of successful project management (6+ years) and evidence of leading role as biostatistician in progressing assets from early development to marketing applications.
- Outstanding ability and skills to effectively represent Biometrics and Data Management in interaction with senior management or cross-functional teams.
- Excellent verbal and written communication, and presentation skills.
- SAS, S-Plus/R, Sample size calculation software (e.g., EaSt, PASS and Nquery)
- Expert R programming skills a major plus.
Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.