Senior Biostatistician

🔥 31 minutes ago

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EDETEK Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2009

💊 Pharmaceuticals

🧬 Biotechnology

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

EDETEK Inc. is a clinical development informatics company that provides a cloud-native R&D Cloud ecosystem and an integrated eClinical platform to support clinical trials and regulatory submissions. Its product portfolio includes CONFORM™ orchestration and collaboration tools, an eClinical Suite (CTMS, EDC, ePRO/eCOA, RTSM), data integration and metadata hubs, a clinical data lake, and statistical computing and submission-ready environments. EDETEK also offers services — biostatistics and programming, clinical data management, clinical study development, medical writing, and eClinical operations — targeting pharmaceutical, biotechnology, and medical device sponsors. The company emphasizes interoperability, data quality, and AI-enabled capabilities to accelerate study execution and regulatory submissions globally.

📋 Description

• Provide statistical support for clinical trials from study start-up through final reporting and regulatory submission. • Contribute statistical input to study design, sample size determination, endpoint definition, randomization, and analysis strategy. • Author or review statistical sections of protocols, statistical analysis plans, mock shells, and other study documents. • Collaborate with sponsors, clinical teams, data managers, statistical programmers, medical writers, and regulatory teams throughout the study lifecycle. • Review statistical analyses and outputs, including tables, listings, and figures, to ensure quality, accuracy, and consistency. • Support interim analyses, safety reviews, efficacy analyses, and final study reporting. • Participate in the review of ADaM specifications, derived endpoints, and analysis datasets. • Support the preparation of DMC materials, including review of analysis outputs and summaries for DMC meetings, in accordance with applicable procedures and confidentiality requirements. • Interpret statistical results and communicate findings clearly to internal teams and sponsors. • Ensure study deliverables are completed on time and in compliance with SOPs, regulatory requirements, and sponsor expectations. • Support responses to sponsor questions, audit requests, and health authority queries related to statistical matters. • Provide guidance to junior statisticians and support departmental process improvement and standardization efforts. • Contribute to proposal development, bid defenses, and budget assumptions as needed. • Support oncology studies involving endpoints such as ORR, DOR, PFS, OS, BOR, CBR, and TTR. • Contribute to statistical strategies for time-to-event analyses, censoring rules, subgroup analyses, and sensitivity analyses. • Support studies using RECIST, iRECIST, or other disease-specific response criteria, as applicable. • Support statistical activities related to DMC/IDMC reviews for ongoing clinical trials. • Assist with preparation and review of DMC analysis outputs, safety summaries, and meeting materials. • Contribute to DMC charter review and statistical content, where applicable. • Work effectively within blinded and unblinded team structures and maintain strict confidentiality.

🎯 Requirements

• Master’s degree or PhD in Statistics, Biostatistics, or a related quantitative field. • Typically 5 to 8+ years of relevant biostatistics experience in clinical research, pharmaceutical, biotechnology, or CRO settings. • CRO experience strongly preferred. • Experience supporting oncology clinical trials preferred. • Experience supporting DMC/IDMC activities preferred. • Strong knowledge of statistical methodology used in clinical trials, including survival analysis, categorical data analysis, and longitudinal data analysis. • Good understanding of ICH, GCP, and applicable regulatory requirements. • Experience developing or reviewing SAPs, protocols, and statistical outputs. • Familiarity with CDISC standards, including SDTM and ADaM. • Proficiency in SAS required. Familiarity with R is a plus. • Strong written and verbal communication skills. • Ability to manage multiple studies and priorities in a fast-paced CRO environment.

🏖️ Benefits

• Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program