The Senior Biostatistician who will be responsible for application of statistical methods, providing statistical inputs, modifications of SAS codes, validation of SAS codes for clinical study data and generation of Tables, Listings and Graphs as outlined in the Clinical Study Protocol and Data Analysis Plan. The Senior Biostatistician will review clinical study protocol and clinical study report as well as work with PK/PD scientists for the development of the Statistical Analysis Plan and SOPs related to Biostatistics activities. Also, the Senior Biostatistician needs to interact with internal teams and external sponsors, auditors and clients.
Duties and Responsibilities:
Provide statistical inputs on study projects, especially in the field of statistical methodologies in study design, sample size estimation, statistical modeling, data handling, analysis and reporting
Work with Biostatistics team to develop and validate SAS codes for the analysis of clinical study data, generate output tables, listings and graphs in according with the study protocol and the statistical analysis plan (SAP)
Work with PK/PD scientists to prepare SAP
Generate randomization scheme for clinical studies
Provide technical advice to junior Biostatisticians as well as Statistical Programmers assigned to the program/projects.
Work with PK/Biostatistics team to prepare and review SOPs
Review statistical outputs and clinical study report
Work with Data Management team to provide inputs for the specifications of domains and the creation of CDISC ADaM datasets
Provide statistical consultations to the clients
M.Sc in Statistics or Biostatistics, experience with SAS/Base, SAS/Macro, SAS/SQL and SAS/Graph
At least 8 years of statistical experience in the pharmaceutical or CRO industry is required.
Strong experience with statistical methods and modeling
At least 3 years of Biostatistician experience in the pharmaceutical industry or in the field of clinical research is required
Proficiency with Microsoft Office
Good interpersonal skills, good communication skills
Attentive to details, good initiative and able to work with changing priorities
2 openings. Telecommuting is allowed.
Internal Number: BPSI #1
About BioPharma Services Inc.
At BioPharma, people matter. Everything we do, and we do it with passion, is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies. Our BioPharma family is key to our success. We create an environment where the brightest minds have space to innovate. Where there are always new opportunities to learn and grow. Where you can feel at home. Our award-winning dynamic teams, specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials, are at the forefront of medical research advances every day. Could this be the right place for you?