Director, Biostatistics

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description: 

The Director, Biostatistics, will be responsible for providing statistical leadership and support for clinical studies that investigate the safety and efficacy of Wave compounds at clinical stage of development (including at Phase 1, Phase 2 or Phase 3). Reporting to the Head of Biometrics, the successful candidate will provide strategic, statistical, and operational leadership to support successful advancement of clinical programs as assigned. Primary responsibilities include collaborating with clinical study teams on clinical trial designs and their implementation; authoring Statistical Analysis Plan (SAP) and working with the statistical programming team to implement the SAP for the assigned clinical trials; delivering analytic results to support Data Safety Monitoring Board (DSMB) and study readouts (at interim or final). In addition, the successful candidate will work with the Head of Biometrics and the Statistical Programming lead closely to continue to improve analysis/reporting processes. The successful candidate should be able to work in multiple therapeutic areas and have a keen interest in learning and applying innovative statistical and machine learning methods, including modelling and simulation, to support the mission of Wave – to deliver life-changing medicines for patients battling devastating genetic diseases. 

Experience: 

• 8 or more years of working experience as a biostatistician for biotech/pharmaceutical companies with a PhD in Statistics, Biostatistics or a relevant field; or 12 or more years of working experience as a biostatistician for biotech/pharmaceutical companies with a MS degree in Statistics, Biostatistics or a relevant field.

Responsibilities:

• Provide expertise and guidance in clinical study design and provide statistical input, including sample size calculation and authoring of Statistical Methods section, to the protocol development from concept discussion, draft to finalization
• Work with multi-functional teams to implement the clinical trial protocols, including being part of the eCRF design and randomization schedule set-up
• Learn and apply statistical and machine learning methodology as needed to address development questions at hand and keep abreast of regulatory guidance and requirements in the global environment with a focus on rare diseases
• Author and drive the review process of ensuring study SAP is thorough and incorporating the input from Clinical Development, Regulatory, Statistical Programming and all other relevant functions; ensure the timeline of SAP development and finalization support the timing of readouts
• Author the shells for tables/listings and description of figures to enable efficient programming for TLFs by Wave Statistical Programming (SP) team or a contracting researching organization
• Review and provide statistical input to the Charter of Data Safety Monitoring Board (DSMB) for the assigned study
• Provide statistical review and support to Wave SP team to create CDISC compliant datasets and ensure the descriptions of derived variables in the specification for ADaM are accurately reflect the SAP
• Be responsible for TLFs deliverables to DSBM as well as to the company for study readouts either at interim or at final
• Be responsible for ensuring a firewall between Biometrics team and clinical teams with respect to unblinded information for randomized, double-blind clinical studies, including working with the Chief Medical Officer (CMO) to set up the process, documenting and communicating of who, when and what a Wave employee can have the access to the unblinded information
• Working with clinical development and medical writing closely to interpretate study results and to develop and finalize Clinical Study Report (CSR), publications of results, and other external results disseminations
• Collaborate and plan effectively with