|Merrimack Pharmaceuticals is a Cambridge, MA based biopharmaceutical company focused on the discovery and development of transformational medicines for complex disease, with an initial focus on cancer. We are committed to providing patients, physicians and the healthcare system with the medicines, tools and information on the diagnosis and treatment of illness through a more precise mechanistic understanding of disease based on our Network Biology approach.
We currently have 5 compounds in oncology clinical trials and a strong pipeline that is expected to produce several more clinical development candidates in the near future.
The Principal Biostatistician will be working with a cross?functional program team as the statistical lead, responsible for statistical activities across multiple studies, and reporting to the program medical director. The ideal candidate is a good communicator, high-energy, self-motivated, and forward?thinking. Experience working in oncology development is preferred, but not required.
Provide leadership and guidance as the statistical expert on a cross?functional program team
Apply statistical expertise to ensure optimal clinical trial designs, analysis methods and data displays
Be accountable for all statistical aspects of protocols and regulatory submissions
Represent Merrimack regarding statistical issues with external parties including regulatory agencies and corporate partners
Work collaboratively with internal and external (e.g. CRO) team members to coordinate the planning and execution of biostatistics deliverables
Work with data management personnel in the preparation of datasets that are of high quality and in usable format
Provide requirements to SAS Programmers to facilitate efficient and effective programming
Be responsible for quality assurance of data produced, the validity of the reported results
and their statistical interpretation
Participate in the establishment of processes and standards for the generation and reporting of data
Contribute to the development of statistical approaches and support for biomarker analysis and translational research.
Ph.D. in statistics with at least 5 years of experience in the pharmaceutical or biotech industry
Demonstrated ability to effectively contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects
Practical experience with application of advanced statistical methodologies to clinical trial design/analysis and with regulatory reporting/submissions
Experience managing outsourced biostatistical services
Proficiency with statistical software tools such as SAS, S-Plus, R, EAST
Familiarity with regulatory requirements and considerations (e.g. GCP, ICH, 21CFRpart11, CDISC)
Positive interpersonal work habits and communication skills
Ability to work independently and act with initiative to address issues
Ability to communicate statistical concepts in a clear and concise manner
Excellent verbal, writing, and presentation skills.
State or Province