Principal Biostatistician

Location
San Francisco, CA, United States
Posted
Sep 06, 2018
Ref
3315-525-2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Position Overview

Provides statistical input into Phase I - IV clinical trial development.

Designs and analyzes clinical trials. Maintains the statistical and analytical integrity of clinical trials analyzed. Participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, and interpreting statistical results for clinical study reports. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on extremely complex problems in which analysis of situations for data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts as the lead statistician on clinical research projects and help with SAS programming. Provides statistical expertise for study design of clinical trial protocols. Writes statistical methods section of the study protocol. Develops statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed. Performs all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data. Performs validation of statistical results. Provides input to key sections of clinical study reports and various regulatory documents. May provide guidance to junior biostatisticians.

A PhD degree in a statistics discipline is preferred. Equivalent experience may be accepted. A minimum of a PhD in a statistics discipline and 3 years experience or Masters in a statistics discipline and 6 years in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required. Excellent analytical skills with the ability to process scientific and medical data is required. Must be able to work independently and in teams. Must have a thorough knowledge of SAS software. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. Must have demonstrated good interpersonal skills. Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.