Mantell Associates
Mantell Associates is currently working on an exciting opportunity for a Senior Biostatistician to join a leading Clinical Research Organization.
Are you passionate about transforming lives through cutting-edge medical research? We are partnering with a premier, full-service CRO renowned for its expertise in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. Our client collaborates with biopharmaceutical and medical device companies worldwide, from emerging startups to global industry leaders.
Senior Biostatistician – Responsibilities:
- Protocol Development: Provide expert statistical input during the planning stages of clinical trials, including study design and CRF development. Engage actively in both internal meetings and client consultations, offering sample size scenarios and design considerations
- Statistical Methodology: Perform detailed sample size calculations and develop comprehensive statistical methodology sections for inclusion in study protocols
- Quality Control: Oversee the production and quality assurance of randomization schedules, statistical analysis plans, and statistical reports, ensuring alignment with integrated clinical reports and other supporting documents
- Analysis Planning: Create thorough statistical analysis plans and table shells in accordance with study protocols, and for integrated efficacy and safety summaries intended for NDA submissions
- Data Management: Design precise analysis file specifications based on the statistical analysis plan and table shells, adhering to CDISC ADaM standards as applicable
- SAS Programming: Develop and validate SAS programs to generate statistical tables, figures, data listings, and perform data mapping from raw datasets to CDISC SDTM datasets
- Regulatory Submissions: Produce and quality control define.pdf, define.xml, and annotated CRFs for SDTM submission, ensuring compliance with regulatory standards
- Clinical Reporting: Write and review statistical sections of clinical study reports and assist in preparing manuscripts for publication
- Project Management: Efficiently manage multiple projects, providing statistical input for Data Monitoring Committee (DMC) activities, including developing DMC charters and analysis plans, and serving as an independent statistician supporting DMC reviews
- Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements specific to therapeutic areas, ensuring the relevance and compliance of statistical methodologies
- Proposal Development: Contribute to proposal development and participate in bid defense meetings. Review RFP and SOW documents to understand project scope, budget, and deliverables
- Team Leadership: Mentor junior staff and effectively manage project budgets and resources to deliver projects on time and within budget
Senior Biostatistician – Requirements:
- Master’s degree in Biostatistics, Mathematics, Statistics, Public Health, or a related field is required
- PhD in these disciplines is highly preferred
- Minimum of 10 years of experience in statistical analysis of clinical trials data
- Proficiency in SAS statistical programming
- Expertise in linear models, mixed models, survival analysis, categorical data analysis, and non-parametric methods
- Strong knowledge of CDISC data standards and regulatory guidelines (GCP, ICH)
- Excellent written and oral communication skills
- Superior project management and leadership capabilities
- Ability to handle multiple tasks and projects with efficiency and precision
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +1 (786) 485 1298.