For over 17 years, Instat has provided comprehensive biometric (data management and statistical) and medical writing services for all phases of clinical drug development. Through the years, we have established a reputation among our clients based on our core values: Client Focus, Depth and Teamwork.

This position is responsible for managing projects that include study design, protocol development, sample size justification, data conversion, and planned and exploratory analyses using SAS in Phase I - IV clinical trials. Coordinate project activities, promote the understanding and communication of trial data, prepare statistical analysis plans (SAPs), design and produce statistical summary tables and perform database integration for analyses. Strong SAS knowledge and experience to work closely with the statistical programming team.

The Senior Biostatistician should have experience equivalent to a PhD in Biostatistics with 4+ years of experience or MSc in Biostatistics with 6+ years of experience in clinical research and/or in the pharmaceutical/biotechnology/device industry.

Essential responsibilities:

• Generate randomization schedules.

• Develop scientifically sound study designs and contribute to study design sections of clinical trial protocols.

• Perform sample size calculations.

• Assist in the design and review case report forms (CRFs).

• Develop statistical analysis plans (SAP), including the development of table and listing shells, to meet objectives defined in protocol.

• Write or review specifications for SDTM/ADaM datasets used to generate the tables, figures, and listings.

• Act as a Project Lead for projects assigned, including coordinating all project team activities and ensuring client expectations are met.

• Work with the Associate Director to monitor project budgets, time spent on the project by the team, and plan appropriate resources.

• Lead the analysis of clinical trial data, oversee all statistical programming on the project and address all issues.

• Program and/or validate statistical summary tables and reports using SAS for planned and exploratory post-hoc and meta-analyses.

• Performs a quality review check on tables, figures, and listings produced for a study.

• Provides a quality review on statistical analysis plan to ensure consistency with protocol and adequacy to meet objectives defined in protocol.

• Provide interpretation of results from statistical analyses or consultation to the clinical project team on any statistical issues related to the trial conduct.

• Perform post-hoc analyses and relevant exploratory analyses of clinical trial data for conference presentation and manuscript submission.

• Function as primary contact for the client, and support clients on project related statistical issues.

• Interacts proactively with the team to expedite the process of locking a clean database and the analysis process for final unblinding.

• Reviews statistical section of clinical study report.

• Handles complex SAS programming issues independently and performs data integration for meta-analyses.

• Reports directly to Associate Director, Biostatistics.

Expectations:

• Good leadership, organizational, and time management skills, with the ability to multitask.

• Must be able to work independently on projects. 

• Familiarity with clinical trial design, CDISC standards, analysis activities and strong knowledge of regulatory guidelines.

• Excellent analytical skills and understanding of statistical analysis methods, with the ability to process and analyze scientific and medical data using SAS.

• Ability to identify and solve complex technical problems.

• Capability to communicate technical concepts clearly and concisely to non-statistical colleagues.

• Effective in working collaboratively across cross-functional teams.