Cambridge - Principal Biostatistician FSP
Cambridge
JOB DESCRIPTION
As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses.
RESPONSIBILITIES
As a Principal Biostatistician, Medical Affairs, your responsibilities include:
- Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies.
- Writes the statistical sections of study protocols, while consulting with internal and external experts.
- Contributes to or prepares statistical analysis plans.
- Collaborates with Data Management and Medical Research on design of eCRFs.
- Provides statistical guidance on conduct of ongoing studies.
- Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
- Contributes observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
- Contributes to scientific articles, summarizing data collected in studies.
- Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed.
- Reviews abstracts, manuscripts for publications and presentations.
QUALIFICATIONS
What we’re looking for:
- PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience.
- Excellent written and oral communication and presentation skills.
- Extensive experience programming in SAS.
- Extensive experiences working on data analysis with clinical studies database
- Experience working on post-approval observational and clinical studies.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Experiences in R programming language and other statistical software.
- Experience with CDISC, including SDTM, ADaM, CDASH.
Cambridge
JOB DESCRIPTION
Who Are You?
An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited...
Abbott LaboratoriesBurlington (MA), 9 mi from Cambridge
for a Senior Biostatistician for either our Maple Grove, MN, Santa Clara, CA or Burlington, MA locations.
The Opportunity
We are seeking an experienced, high caliber Senior Biostatistician to join Abbott’s medical device clinical research organization...
Cambridge
JOB DESCRIPTION
As Medical Affairs Biostatistician, you are responsible for statistical activities in support of Medical Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing...