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Sr. Biostatistician

Syneos Health
San Rafael, California, United States
Based on experience
February 28, 2018

We have a need for a Sr. Biostatistician.

• Keep abreast with advanced statistical analysis methods and results/data presentation formats of clinical data.

• Collaborates with Medical Monitor, Clinical Research Associate (CRA), Medical Writer, Clinical Data Management (CDM), and Statistical Programmer in developing a clinical study protocol, case report forms (CRFs), and edit checks.

• Provides a sample size based on the specification provided by Medical Monitor.

• Develops a statistical analysis plan for a clinical study or publication.

• Develops analysis specifications for Statistical Programmer and reviews/verifies analyses and programming codes for quality assurance.

• Participates in development of standard reporting programs for clinical studies.

• Participates in development of standard CRFs for clinical data collection.

• Participates in regulatory submissions including CSR, IND safety update, Annual Report/PSUR, and integrated summaries of safety and efficacy in NDA and BLA Ensures the quality of data and accuracy of analyses in regulatory submissions (e.g., CSR) or publications.

• Develops SOPs, guidelines, and template.

The candidates should meet following requirements:

(1) MS degree in Statistics or closely related field, PhD preferred and

(2) 5 years of industry experience, oncology experience preferred.

Basic Qualifications:

• Experience with writing/reviewing statistical analysis plans, working on study protocol, study design, and ad hoc analysis

• Possesses strong SAS programming skills

• In-depth knowledge of clinical development including clinical operations, data management, and clinical study report preparation workflow

• North American or European regulatory experience and in-depth knowledge of FDA/EU regulations and guidelines

• Must be knowledgeable of statistical methods in clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS), and regulatory regulations/guidelines.

Preferred to have worked on electronic NDA and/or BLA submissions via e-CTD.

• Excellent oral and written communication skills

• Ability to work on cross-functional teams is crucial

• Works well on a project team and possesses flexibility