Adrian Olszewski's Linkedin Analytics

For 13 years I've been developing my skills in clinical trials biostatistics (frequentist; non-Bayesian) across diverse therapeutic areas, supported by advanced statistical programming in R. I'm experienced in integrating R into controlled, numerically validated environments. ⛔ I'm NOT a Data Scientist (no ML/AI methods) ⬇️ Details: ⧮ Experience (years): ⦿ Biostatistics: 13 ⦿ Writing SAPs: 11 ⦿ Programming in R: 21 ⦿ TFL shells: 11 ⦿ SDTM & ADaM: 2 ⦿ Database design (ERD) & querying (SQL): 15 I hold MSc in Computer Science. No degree in stat/math. ⧮ Trials ⦿ RCT phase IIa/b (PK), III ⦿ RWE: pro-/retrospective observational ⧮ Therapeutic areas: asthma · oncology · rheumatology · osteoporosis · orthopaedics (osteogenesis, skeletal events) · dyslipidemia · anaemia · cardiology: rhythm disorders + cardiovascular diseases · thrombophilia · periodontology ⧮ Scope of activity: trial design: fixed & adaptive; multi-arm, cross-over/parallel + sample size & power · SAP+TFLs · randomization · analysis, programming, report · SOP ⧮ Selected topics in statistics: ⦿ Descriptive & inferential statistics: estimation & testing hypotheses: NHST + MCID (non-inferiority, equivalence, superiority). ⦿ Effect size: a variety of measures ⦿ classic (MVT, Bonferroni, Holm, etc), fallback, gatekeeping, sequential, graphical (CTP) control of FWER ⦿ Modern non-parametric, robust, bootstrap & permutation methods ⦿ Modelling: General(ized) (non-)Linear/Additive (Mixed) (Quantile) Models · diagnostics ⦿ AME/MEM (LS/EM-means)/G-calc ⦿ Exact, Firth, etc. ⦿ Contingency + questionnaires (+ Likert) ⦿ Longitudinal analysis ([c]LDA, ANCOVA post/change), pre-post: conditional (mixed models) & population-average (MMRM via GLS & GEE) ⦿ Type 2/3 analysis of main and interaction effects (n-way [RM]-AN[C]OVA). Simple effects / planned contrasts. · Wald, LRT, Rao ⦿ PCA, (E)FA ⦿ Missing data: RBMI/MICE/DR/*OCF, MNAR sensitivity / tipping-point ⦿ Estimand framework ⦿ Survival analysis: * Scope: - Estimation & comparison of: survival prob./CIF, quantiles, RMST · [weighted] LogRank/Fleming-Harrington: Max-Combo/Tarone-Ware/Gehan-Breslow/Peto; Gray - Regression: (semi-)parametric · (non-)proportional hazards · time-dependent covariates · unequal effects & baseline hazards (strata) · recurrent events & competing risks (counting models, sub-distribution) + combined (joint frailty) * Selected tools: Kaplan-Meier/Nelson-Aalen/Aalen-Johansen · Cox (+extensions: AG/PWP/FG), AFT, Frailty Models · landmark an. · MCF ⦿ PharmacoKinetics ⦿ G-calc, IPTW, matching ⧮ Guidelines: ICH, CONSORT, FDA, RECIST