My client, an emerging leader in Clinical services and software solutions for the life sciences industry, is looking for a Principal Biostatistician to join their team. With have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions they support clients to focus on their core strengths. For early phase studies through Phase III clinical trials, their experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
DESCRIPTION
The Principal Biostatistician, Clinical Data Systems and Services should possess robust statistical expertise, providing comprehensive support and analysis for clinical studies. Skilled in study design, reporting, and regulatory engagement, including FDA and EMEA communications. Experienced with CDISC standards, SAS proficiency, and DMC/DSMB support. Actively engage with clients and support sales through expert statistical solutions and SOP development.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Possess a strong understanding of statistical principles and demonstrate strong statistical skills
Provide comprehensive statistical support throughout clinical studies
Conduct statistical analyses of clinical data and interpret the results, focusing on the efficiency and safety of drug molecules or study goals
Experienced in calculating sample sizes, developing concepts and protocols for studies, creating Statistical Analysis Plans (SAP), and preparing clinical study reports, including integrated summaries for regulatory submissions
Engage with regulatory bodies such as the FDA and EMEA, preparing statistical documentation and effectively communicating statistical plans and results in professional forums.
Provide support for Data Monitoring Committees/Data Safety Monitoring Boards (DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB support. This encompasses interim analysis, TLF shells, both blinded and unblinded reports, and organizing kick-off meetings
Solid understanding and implementation of Clinical Data Interchange Standards Consortium (CDISC) requirements for regulatory submissions, including experience with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications generation and quality control of datasets
Extensive hands-on experience in statistical analysis using SAS, including creating mock shells for tables, listings, and figures (TLFs), and validating TLFs for New Drug Applications (NDA) and Biologics License Applications (BLA) submissions
Actively engage with clients to understand their statistical and analytical needs, providing expert advice and solutions. Support the sales cycle by contributing to proposals, presentations, and discussions that showcase our statistical capabilities and how they meet client requirements
Responsible for the creation and updating of Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions
EDUCATION AND EXPERIENCE REQUIRED
10+ years of experience as Biostatistician and working in a CRO/Pharma/Biotech company
3+ years of experience in leading team of biostatisticians and statistical programmers and working in a CRO/Pharma/Biotech company
MSc or PhD in Biostatistics or Statistics
Strong written and verbal communications skills, including proficiency in the English language with the ability to explain complex statistical concepts to non-statisticians
Proficient in statistical programming languages such as SAS, R, or Python
Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures, TLFs proficiency
Capable of directing and promoting teamwork in a multi-disciplinary team setting
Strong knowledge of regulatory guidelines and statistical methodology related to clinical development
Excellent written and verbal communications
Coach/mentor new team members to support efficient and quick on-boarding
Cross functional collaboration & Stakeholder management
Strong knowledge of ICH guidelines
