Associate Director/Director, Biostatistics

Our Culture: Why work with us?  

We value the diversity of backgrounds, ideas, opinions, and life experiences that our team members bring to Candel. There’s a dedication to one another that’s palpable. We hire kind, smart, creative, trusting, passionate professionals who are always learning, and teaching and putting the patient first.  We’re incredibly proud that as we’ve grown, our vibrant culture has remained steadfast. We continue to build a culture of collective hard work without egos, instilling mutual trust and accountability. Our Leaders are accessible, authentic, and invest in their employees.  We believe in giving team members freedom with accountability”, meaning our focus is on results, not where and when employees work. “We’re all in this together,” is our company motto.

Our Science:

Candel Therapeutics is a clinical-stage biotechnology company pioneering the development of viral based immunotherapies for the treatment of solid tumors. Candel’s products are designed to significantly help patients fight their cancer while maintaining quality of life.  We have a robust pipeline with clinical assets in phase 1, 2 and 3 for the treatment of prostate, brain, lung, and pancreatic cancers. Candel is a newly public company having completed its IPO at the end of July 2021. Please visit www.candeltx.com for additional information.

What’s in it for you:

This role is a highly visible position with significant impact to the company. This role will require strong communication and presentation skills, leadership, creativity, independence, a strong collaborative attitude, and a willingness to roll up the sleeves for hands on statistical analyses and support. You will be provided with a great opportunity to expand your knowledge, scope and impact, particularly as we are actively building our drug development team (including biostatistics and data management) to support our pipeline.

As an Associate Director/Director of Biostatistics, you are a creative and strategic thinker and will serve as the statistical SME in cross-functional teams for strategic planning, execution for the product development plans, trial design, statistical analysis plan, and execution of that plan. You will support our BLA readiness as well as overseeing our study data standardization and CRO interactions related to data analysis. The Candel team is on a critical mission to bring impactful new medicines to cancer patients. This role will help us deliver that objective while truly putting patients first.

A day in the life of this role:

Strategy and Leadership

  • Serve as in house Biostatistics lead for multiple oncology studies
  • Provide strategic input to innovative study design, protocol development, and lead development of the statistical analysis plan
  • Champion innovative approaches to study design with the objective of improving study efficiency and decision making via statistical tools and models
  • Support IND, BLA and other submissions and interactions with FDA and other Health Authorities
  • Define statistical resource needs and determine use of in-house, contractors, or CROs as appropriate to support needs across the portfolio
  • Ensure integrity of data collection, review, compilation and analysis by monitoring protocols and procedures; identify scientific problems; suggest and implement corrective action

Operational

  • Oversee and/or perform data analysis for oncology clinical trials, including interim, exploratory, and final study analyses.
  • Contribute and oversee proper execution of statistical analysis plans; determine proper summary statistics, report formats and address analysis considerations
  • Develop randomization and blinding plans
  • Review and oversee vendor data, data mappings, analysis dataset specifications and derivations, and analysis deliverables
  • Oversee statistical programming efforts to support planned analyses, including clinical study reports, routine safety reporting, and regulatory agency filing activities
  • Assist in data review and generation of data quality checking reports
  • Develop project milestones, timelines, and budgetary management where appropriate

What will make you a good fit with this role:

  • Perseverance: You have a “can do” attitude and don’t mind rolling up your sleeves and pitching in. You always go above and beyond.
  • Intellectual curiosity: You enjoy thinking deeply. You have a thirst for learning. You relish in sharing knowledge and know how to have fun doing so!
  • Daring: You are comfortable taking risks and (appropriately) pushing boundaries. You work hard and challenge the status quo.
  • Comradery: You build genuine relationships. You trust your co-workers. You truly enjoy working together and understand we are all more successful when we work as a team.

 What we’ll need from you:

  • MSc/PhD in Statistics or Biostatistics, with 7-12 years of biopharmaceutical industry experience
  • Experience providing statistical support for Ph1-3 trials
  • Experience with Agency interactions and regulatory filings (NDA/BLA) strongly preferred
  • Knowledge of FDA and ICH guidelines and industry standards
  • Experience in R programming language, SAS, knowledge of CDISC and SDTM
  • Excellent written, verbal and inter-personal skills; ability to translate and effectively communicate complex information and concepts to non-statisticians

Corporate Culture:

A fundamental belief held by the Candel Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.  Please visit www.candeltx.com for more information.

We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology.  For consideration, please submit CV.

Interested candidates please submit your resume to careers@candeltx.com