As a Senior Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. Experience Stats, supporting the activities like performing ad-hoc or exploratory analyses to support submission or Health Authority Questions. It will be good to have some regulatory work experience, for example, understanding the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues (with minimal supervision from Project stats).

Summary of Job Responsibilities:

• Providing statistical support to clinical studies.

• Participating in the development of study protocols, including participation in study design discussions and sample size calculations reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications.

• Performing statistical analyses.

• Interpreting statistical results.

• Preparing clinical study reports, including integrated summaries for submissions.

• Utilizing your strong communication skills to present and explain the methodology and consequences of decisions in lay terms.

• Serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.; being adaptable and flexible when priorities change.

Qualifications and Experience:

• Master’s degree in statistics or a related discipline. Ph.D. strongly desired.

• 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO is strongly desired.

• Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.

• Knowledge and implementation of advanced statistical methods.

• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.

• Strong knowledge of ICH guidelines.

• Solid understanding & and implementation of CDISC requirements for regulatory submissions.

• Adept in ADaM specifications generation and QC of datasets.

• Submissions experience

• Experience working with cross-functional teams, a Study Management Team (SMT), or similar teams for different clients.

• Effective communicator: able to explain methodology and consequences of decisions in lay terms.

• Team player; willingness to go the extra distance to get results, meet deadlines, etc.

• Ability to be flexible when priorities change and deal with ambiguity.