Director, Biostatistics

Wave Life Sciences

  • Lexington, MA
  • Permanent
  • Full-time
  • 28 days ago
Job Description: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 internal and external statistical programmers and data managers to ensure Biometrics deliverables at study level are of high quality and meet timelines
  • Provide oversight and guidance to external resources including contract research organizations and contractors
  • Communicate effectively with internal team members and senior management
Key Skills:
  • Comprehensive knowledge of statistical and machine learning methodology with demonstrated ability of applying advanced and/or novel methods in clinical trial design and data analysis
  • Excellent communication and writing skills including the ability to clearly describe advanced statistical methods to non-statisticians and interpret results
  • Extensive knowledge in SAS analytic procedures with experience of using SAS to perform statistical analyses; experience with conducting statistical simulations and using simulation results to solve problems and/or address challenging topics at hand using up-to-date working knowledge of R, SAS, and python
  • Detail-oriented, flexible, well-organized, and able to work well in a fast-paced environment and under pressure as an excellent team player
  • Working knowledge of regulatory guidelines for drug development, NDA submissions, and statistical practices (e.g., CTD guidance, ICH guidelines), especially in drug development for rare diseases
Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

Wave Life Sciences