Biostatistician / Statistical Programmer

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the development of autologous and off-the-shelf, allogeneic therapies targeting solid tumors. Tessa’s Virus-Specific T cell (VST) platform harnesses the body’s potent anti-viral immune response and has shown compelling results in the treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by combining the qualities of VSTs with other immuno-oncology technologies. This includes a rapidly growing pipeline of clinical and pre-clinical autologous programs that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, as well as head and neck cancer. In addition, Tessa is leveraging its platform to develop an allogeneic therapy to address Epstein-Barr virus (EBV)-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to successfully deliver T cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies. We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

Job Position

Biostatistician / Statistical Programmer

Reports to

Head of Biostatistics

Summary

The Biostatistician / Statistical Programmer is responsible for providing high quality statistical and statistical programming expertise on assigned studies. As a key member of the clinical development team, the Biostatistician / Statistical Programmer will collaborate cross-functionally to ensure a high level of rigour is brought to the design of studies, and the analysis, reporting and interpretation of results. In addition to study-level work, the Biostatistician / Statistical Programmer will have the opportunity to contribute to non-study related projects where innovative statistical and programming solutions are needed to solve complex drug development problems.

Job Description

  • Collaborate with the clinical team to design studies, write protocols, review case report forms, interpret results, write clinical study reports and external publications.
  • Manage the oversight of CRO statisticians and statistical programming groups to develop high quality statistical analysis plans, specification documents, and CDISC-compliant statistical deliverables (SDTM & AdaM data sets, Tables, Listings, Figures).
  • Apply extensive programming expertise in SAS and other analytical software to clinical trial applications, including simulations to evaluate different study designs.
  • Work closely with data management and clinical research/clinical operations personnel to develop study-specific data capture activities and processes to ensure data integrity.
  • Develop technically sound, highly innovative statistical solutions to complex analytical problems.

Requirements

  • Master’s Degree or PhD in Statistics or a related discipline
  • Minimum of 3 years’ experience performing clinical trial statistics or statistical programming
  • Strong analytical skills and sound knowledge of theoretical and applied statistics
  • Excellent data manipulation, analysis and reporting skills using SAS
  • Working knowledge and ability to implement the latest CDISC SDTM and AdaM standards
  • Curiosity to learn and find creative, fit-for-purpose solutions to drug development problems
  • Excellent oral and written English communication skills
  • Strong ability to collaborate effectively across functional groups
  • Good organisational skills, sufficient to multi-task in a fast-paced environment
  • Experience with oncology trials would be an advantage