Author and provide statistical contributions, statistical review and quality control (QC) of SAPs; Table, Figure, and Listing (TFL) shells;
Data Monitoring Committee (DMC) Charters; Submission Data File (SDF) specifications (SDTM and ADaM); randomization specifications;
other key study related documentation, protocol deviations, data quality review, and other communications
Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to Case Report Form (CRF) development, database specifications review, database development, Interactive Voice Response System (IVRS) specification review
Participate in Clinical Study Team (CST) meetings following study design completion, representing Biostatistics at the CST
Proactively discuss important statistics issues with cross-functional members of the CST and respond to statistics queries raised by members of the CST
Complete statistical analysis of studies / projects
Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints (programmatically)
Create required outputs for Dose Level Review (DLRM) meetings
Review TFLs created by statistical programming for consistency and accuracy
Collaborate with the study programming team for study deliverables
Manage timelines for all statistics-related deliverables
Initiate cross-functional team meetings as necessary
Be familiar with all Company’s policies, Standard Operating Procedures (SOPs) and other controlled documents related to study activities noted above
Assist with study and systems audits conducted by Company Global Compliance Audit (GCA) and external bodies
Basic Qualifications :
Master’s degree in Statistics / Biostatistics (or other major with high statistical content) with 2 years post-graduate experience as a statistician in the pharmaceutical industry or medical research
Doctoral degree in Statistics / Biostatistics (or other major with high statistical content) with 1 year post-graduate experience as a statistician in the pharmaceutical industry or medical research
Ability to clearly communicate in English, including statistical information (written and oral)
Competent programming skill in at least one statistical software package (SAS or R)
Experience in the application of statistics in the analysis and conduct of clinical trials
Knowledge of current CDISC standards for SDTMs and ADaMs such that there is an ability to implement the standards
Preferred Qualifications :
Master’s degree in Statistics / Biostatistics (or other major with high statistical content) with 4 years post-graduate experience as a statistician in the pharmaceutical industry or medical research
For Doctoral degree in Statistics / Biostatistics (or other major with high statistical content) with 2 year post-graduate experience as a statistician in the pharmaceutical industry or medical research
Prior leadership of at least 1 study / project with minimal oversight
Prior experience designing, analyzing and / or reporting clinical trials within Pharmaceutical / Biotechnology / Public Health setting in Industry, Government or Academia
Prior experience in the development and execution of protocol and Statistical Analysis Plan (SAP), as well as review of a Clinical Study Report (CSR) at least 3
Prior experience overseeing the completion of multiple tasks simultaneously
Prior experience implementing current CDISC standards for SDTMs and ADaMs
Required Experience :
Strong understanding of statistical concepts related to the design and conduct of clinical studies
Understanding of the clinical development process for pharmaceutical products and the role of a statistician throughout the development process
Why Work at Parexel
There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.
The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?
A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.
Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.