Proclinical is currently recruiting for a Lead Biostatistician with a biotechnology company located in Philadelphia, PA. Successful candidate will contribute to and oversee multiple aspects to clinical trials including, but not limited to, study design; the statistical analysis plan; analysis data sets; planned, ad hoc, and exploratory statistical analyses; and summary outputs. The successful candidate will also contribute towards creating departmental systems, standards, and processes.
- Evaluate and compare the operating characteristics of competing clinical study designs.
- Write statistical sections of study protocols.
- Write or oversee the writing of statistical analysis plans.
- Develop or review shells and programming specifications for TFLs.
- Review CDISC data sets and CDISC data set specifications.
- Oversee or perform ad-hoc and exploratory analyses to support publications and internal decision making.
- Develop and assist with the development of standard operating procedures and work instructions for biostatistical activities relating to clinical trials and with the qualification and/or validation of statistical computing environments, statistical software, and statistical outputs.
Skills and Requirements:
- MS or PhD in Biostatistics, Statistics, or related field.
- Industry knowledge of the drug development lifecycle including both early- and late-stage oncology clinical trials, CDISC standards, Extensive knowledge of Health Authority requirements
- Programming skills in both SAS and R.
- Excellent written and verbal communication skills.
- A proven ability to solve problems, working independently of others.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicole Aganon at (+1) 347-293-1161 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.