Principal Biostatistician

Job Description
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.

Job Responsibilities:

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.

Requirements:

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.

Company

Merrimack Pharmaceuticals

Job Code

State or Province

Massachusetts

Apply
Print  Close
Terms and Conditions I 2000-2020 Candidate Seeker, Inc. I 1994-2020 Brolin Corporation
   Powered by Portal Prodigy