RESPONSIBILITIES

The Senior Biostatistician will support clinical trial activities in accordance with industry standards for research, and relevant regulations and guidance documents.

Responsibilities will include activities that support the planning, analysis, review, and interpretation of clinical data sets from research projects and protocols conducted by the clinical research group. Activities will include, but are not limited to, working with study team members on pre-study planning, protocol development (in particular, the statistical section of the protocol including sample size/power calculations), Statistical Analysis Plan preparation/review, oversight of the biostatistical activities of contractors and contract research organizations (CRO), data quality reviews, and review of tables/listings/figures and clinical study reports. Some SAS programming is required in response to requests from Clinical and other departments, and could include preparation of data distributions and data sets, and ad hoc listings and data analysis.

REQUIREMENTS

Education: A Master?s degree (or equivalent) in a research field ? eg, statistics, biostatistics, epidemiology, psychology.

Experience: A minimum of 6 years industry and/or CRO experience with the design and analysis of clinical trials is required; 3 years of experience in a pharmaceutical or biotech sponsor organization is preferred. Demonstrated knowledge of applied clinical research statistics in support of pharmaceutical and/or biologics product development is required. The work history should demonstrate evidence of the ability to effectively manage numerous projects simultaneously and in an efficient manner. Experience with verbal and written communications with the FDA (CDER and/or CBER preferred) is required; experience with European regulatory filings and/or European clinical studies is preferred. Some experience with management of outside contractors/CROs is preferred.

Proficiency in basic SAS programming is required (eg, DATA steps, basic SAS procedures). Knowledge of SQL, EXCEL, and SAS Graphics is a plus.

LOCALE

Lexington, MA. USA

CONTACT

LAURIE COLWELL
MRI of HYANNIS
lcolwell[at]masshire.com
508-771-2506 x203

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