Associate Director, Biostatistics

Associate Director, Biostatistics

CK Science are seeking an Associate Director, Biostatistics with experience in Phase I Clinical trials with extensive experience in Oncology or Immuno-oncology. 

This position will lead, develop, and implement statistical analyses to support our early development clinical trials, and provide support to investigators and researchers on experimental design and statistical approaches, requirements, and scientific standards. This role will report to the Head of Biometrics, is hands-on and requires excellent communication skills and frequent collaboration with multiple internal groups. The successful candidate can work independently and thrives in a proactive can-do culture. The work will be fast-paced with evolving needs, requiring adaptability, curiosity, and grace under pressure. This role is an exciting opportunity to be a critical part of the clinical development group, involved in the design, execution, analysis, and reporting of our clients clinical studies. 

Location: Boston, MA. Onsite 4 days per week.

Responsibilities:

• Serve as the biostatistician in the Clinical Operations and Development team, responsible for all clinical study biostatistics deliverables
• Analyze and interpret data from various sources, using standard statistical analysis software to perform appropriate statistical analyses on clinical trial patient data
• Develop statistical sections of protocols and statistical analysis plans and assist in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses from regulatory agencies
• Make recommendations on appropriate study design, methodology, analytic and operational approach, sample size and power considerations
• Ensure that clinical trials meet statistical requirements (ICH, FDA, EMA guidelines) and are conducted with appropriate rigor
• Provide ongoing reporting of clinical trial data as needed
• Perform exploratory data analyses on patient subgroups
• Collaborate with translational science and pharmacokinetic colleagues as needed to analyze early phase trial data
• Maintain knowledge of current and emerging trends in state-of-the-art statistical and analytic techniques
• Collaborate with, and manage internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to meet project timelines and achieve goals
• Collaborate with cross-functional team to review study results and contribute scientific knowledge and analytical skills to the production of documents

Qualifications:

• Ph.D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master’s degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations
• Ability to analyze, interpret, and summarize clinical and scientific data using a range of advanced statistical techniques for statistical analyses
• Skill in preparing graphical data displays
• Knowledge of scientific approach and methodologies as well as principles, concepts, methods, and standards of statistical research
• Solid understanding of drug development, clinical research, study design, pharmacokinetics, and medical terminology
• Experience with CRO vendor oversight is preferred
• Experience in oncology and oncology statistical methods used is preferred
• Working knowledge of data management principles and regulatory requirements for clinical trials and medical research, including relevant ICH guidelines, US, EU and other regions’ regulations
• Strong organizational and analytical skills, with the ability to be proactive, think strategically and manage multiple projects simultaneously
• Ability to interact effectively with team members, proactively facilitating effective information exchange, with strong communication and problem-solving skills
• Ability to excel in a fast-paced, highly collaborative work environment with a multi-disciplinary and diverse team

Apply:

It is essential that applicants hold entitlement to work in the US. Please quote job reference 103613 in all correspondence.