Clinical SAS interview Q&A

Definition of Best Overall Response (BOR) Best Overall Response (BOR) is the best treatment response a patient achieves during a clinical trial. It is determined based on tumor size changes and classified into four categories: 1.Complete Response (CR) – The tumor disappears completely. 2.Partial Response (PR) – The tumor shrinks significantly but is still present. 3.Stable Disease (SD) – The tumor neither shrinks nor grows significantly. 4.Progressive Disease (PD) – The tumor grows or worsens. Imagine 5 patients are taking a new cancer drug. Each patient’s response is tracked over time. •If a patient improves over time, the best response is counted (e.g., PR → CR → CR is recorded as CR). •If a patient worsens after improvement, the worst response is counted if the patient does not recover •(e.g., PR → PD is recorded as PD). Imagine 5 patients are taking a new cancer drug. Each patient’s response is tracked over time. •If a patient improves over time, the best response is counted (e.g., PR → CR → CR is recorded as CR). •If a patient worsens after improvement, the worst response is counted if the patient does not recover •(e.g., PR → PD is recorded as PD). Patient Response Type Best Overall Response (BOR) Patient 1 CR (Tumor disappeared) CR Patient 2 PR (Tumor shrank) PR Patient 3 SD (No significant change) SD Patient 4 PR first, then PD later PD (worst response counts) Patient 5 PR first, then CR later CR (best response counts) PR → CR → CR → CR 👉 BOR = CR (Best was 100%)SD → PR → PR → SD 👉 BOR = PR (Best was 80%)PR → SD → PD → PD 👉 BOR = PD (Got worse at the end)SD → SD → SD → SD 👉 BOR = SD (No change)PR → CR → PD 👉 BOR = PD (Got worse at the end)Definition of Objective Response Rate (ORR) Objective Response Rate (ORR) is a measure used in oncology clinical trials to assess how well a treatment works. It is the percentage of patients whose cancer shrinks (Partial Response – PR) or disappears (Complete Response – CR) after treatment. ORR does not include Stable Disease (SD) or Progressive Disease (PD). A 95% Confidence Interval (CI) is a range of values that tells us where the true result is likely to be. What is a 95% Confidence Interval (CI)? 95% Confidence Interval (CI) for Objective Response Rate •Drug A: (0.1941 – 0.993) → This means we are 95% sure that the true response rate for Drug A is between 19.41% and 99.3%. •Drug B: (0.0250 – 1.000) → The response rate for Drug B is between 2.5% and 100% (very wide range due to low patient count).95% Confidence Interval (CI) for Objective Response Rate •Drug A: (0.1941 – 0.993) → This means we are 95% sure that the true response rate for Drug A is between 19.41% and 99.3%. • •Drug B: (0.0250 – 1.000) → The response rate for Drug B is between 2.5% and 100% (very wide range due to low patient count).Difference in Objective Response Rate •0.75 (75%) → Drug A had a 75% higher response rate than Drug B.95% CI for the Difference in ORR •0.3257 → This means the actual difference could vary, but there’s a 32.57% chance that Drug A is better than Drug B.P-value •0.2207 → The p-value tells us if the difference between Drug A and Drug B is statistically significant. •Since 0.2207 > 0.05, this means the difference is not statistically significant, meaning we cannot be sure that Drug A is truly better than Drug B (the result could be due to chance).

1. Study Title: A Randomized Phase 3 Study of MRTX949 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation Objectives: Primary Objective: Secondary Objectives: Endpoints: Primary Endpoint: Secondary Endpoints: 2. Study Title: An Open-label Phase 1b Study of ORIC-101 in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumors Objectives: Primary Objectives: Secondary Objectives: Exploratory Objectives: Endpoints: Primary Endpoints: Secondary Endpoints: Exploratory Endpoints: 3. Study Title: Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma Objectives: Primary Objective: Secondary Objectives: Exploratory Objectives: Endpoints: Primary Endpoints: Secondary Endpoints: Exploratory Endpoints: 4. Study Title: A Phase-2 Open-label Multicenter Study of Single Agent Enzastaurin in Patients with Relapsed Cutaneous T-cell Lymphoma Objectives: Primary Objective: Secondary Objectives: Endpoints: Primary Endpoint: Secondary Endpoints: 5. Study Title: Evaluating the Efficacy and Safety of Pembrolizumab Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial Objectives: Primary Objective: Secondary Objectives: Exploratory Objectives: Endpoints: Primary Endpoint: Secondary Endpoints: Exploratory Endpoints:

1. A Randomized Phase 3 Study of MRTX949 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC) with KRAS G12C Mutation Primary Objective: Secondary Objectives: 2. An Open-label Phase 1b Study of ORIC-101 in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumors Primary Objectives: Secondary Objectives: Exploratory Objectives: 3. Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma Primary Objective: Secondary Objectives: Exploratory Objectives: 4. A Phase-2 Open-label Multicentre Study of Single Agent Enzastaurin in Patients with Relapsed Cutaneous T-cell Lymphoma Primary Objective: Secondary Objectives: 5. Evaluating the Efficacy and Safety of Pembrolizumab Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled TrialPrimary Objective: Secondary Objectives: Exploratory Objectives:

Overview: With over 11 years of experience in SAS Clinical Programming, I have contributed to multiple high-impact clinical trials across various therapeutic areas. Below is a snapshot of some of my recent projects, highlighting my roles and expertise: Recent Projects 1. Phase 3 Study: MRTX949 vs. Docetaxel in NSCLC with KRAS G12C Mutation 2. Phase 1b Open-label Study: Active Drug + Anticancer Therapy in Advanced/Metastatic Solid Tumors 3. Phase 1 Trial: Intralesional Immunotherapy with Active Drug Vaccine in Merkel Cell and Cutaneous Squamous Cell Carcinoma 4. Phase 2 Multicenter Study: Enzastaurin in Relapsed Cutaneous T-cell Lymphoma 5. Phase 3 RCT: Efficacy and Safety of Pembrolizumab vs. Placebo in Advanced NSCLC 6. Bioequivalence Study: Solifenacin Succinate Tablets in Healthy Adults

Ravikumar. katkamxxxx.COM+91 9xxxx Professional Summary: Professional Skills: SAS Skills: BASE-SAS, SAS/MACRO, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, SAS Enterprise Guide.Programming Languages: SQL, SAS.CDISC: SDTM, ADaM. Education: Professional Experience: Senior Statistical Programmer IQVIA (Home-based) – Dec 2014 to Present ———— Recent Projects: Project 1: A Randomized phase 3 study of MRTX949 versus Docetaxel in patients with previously treated Non-small cell lung cancer with KRAS G12C Mutation Project 2: An Open-label Phase 1b Study of Active drug in Combination with Anticancer Therapy in Patients with Advanced or Metastatic Solid Tumours. Project 3: Phase 1 Trial of Intralesional Immunotherapy with Active Drug Vaccine in Patients with Advanced Merkel Cell Carcinoma or Cutaneous Squamous Cell Carcinoma. Project 4: A Phase-2 Open-label Multicentre Study of Single Agent Enzastaurin in Patients with Relapsed Cutaneous T-cell Lymphoma. Project 5: Evaluating the Efficacy and Safety of Pembrolizumab Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial Project 6: An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Solifenacin Succinate Tablets 10 mg with (Solifenacin Succinate) Tablets 10 mg in Healthy, Adult, Human Subjects Under Fasting Conditions. Responsibilities: