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Roivant Sciences // biomedical research
 
Roivant Sciences, 151 West 42nd Street, 15th Floor, New York City 10036    Posted: Tuesday, March 30, 2021
 
   
 
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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

Position Summary:

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.

Responsibilities:

  • 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.
 
 
 
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