Thalis Tsaklas

Statistician with a MSc in Statistics, experienced in leading, and/or providing support to Phase I to Phase III studies across multiple therapeutic areas. 4 years of experience in statistical and programming aspects of clinical research, including writing/reviewing CDISC-compliant data specs, programming/validating safety and efficacy SDTM and ADaM datasets, and TFLs, including complex statistical analyses. Additionally, experienced in producing randomisation schemes, writing/reviewing study-level and integrated (ISS, ISE) mock TFL shells and SAPs, reviewing and contributing to clinical study protocols, eCRF designs, protocol deviations lists and plans, statistical reports, safety narratives reports, DMC charters, CSRs, and (un-)blinding plans. Ensure healthy communication with sponsor, cross-functional teams (Programming, DM, Safety, Clinical, PK), and external vendors.

Adhere to applicable SOPs, GCP, GDPR and ICH principles. Experienced in PK, PD, ADA endpoints and in respiratory, oncology, immunology, infectious disease (COVID-19), and rare disease therapeutic areas. Attention to detail, persistent, strong focus on delivering to time and quality expectations.

Strong leadership, communication skills, and willingness to support and mentor others. Ability to work both within a team environment and independently, as required.