Lead or support Phase I-III clinical studies (Alzheimer's, Type 2 Diabetes) by designing studies, calculating sample sizes, writing SAPs, performing and interpreting statistical analyses, preparing clinical study reports and submissions, ensuring CDISC/ADaM compliance, QCing outputs with SAS/R, and collaborating with cross-functional teams.
As Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies specially focusing on Alzheimer’s and Type 2 Diabetes.
ResponsibilitiesAs a Principal Biostatistician, your responsibilities include:
- providing statistical support to clinical studies, with a focus on Hypertension;
- 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;
- leading study activities when called upon;
- utilizing your strong communication skills to present and explain 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
What we’re looking for:
- Master’s degree in statistics or a related discipline. PhD strongly desired.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO 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 and R programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirement 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.
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