What are the responsibilities and job description for the Statistician position at WuXi AppTec Inc?
Overview
Pharmapace, Inc. (“Pharmapace”) is a consulting and contract Clinical Research Organization (“CRO”) founded by a group of veteran leaders in the biotech/pharmaceutical industry who are recognized experts in their respective fields. Pharmapace’s core mission is to deliver exceptional value to biotech/pharmaceutical companies by providing high-quality consulting and outsourcing services to support our customer’s clinical trials, regulatory submissions, medical affairs, safety surveillance, and outcomes research programs to help patients afflicted with a wide range of disease conditions.
The primary responsibilities of this position are to assist with study level statistical related activities, particularly to write statistical analysis plans, prepare mock tables/figures/listings, and generate statistical analyses for clinical studies.
Responsibilities
ESSENTIAL JOB FUNCTIONS
- Review study protocols and assist with protocol preparation
- Assist with sample size and power calculation
- Assist with randomization schedule generation
- Review case report forms to ensure appropriate data collection
- Review edit checks algorithm to ensure data quality for statistical analyses
- Participate in study team operations and timeline discussion
- Prepare statistical analysis plans
- Prepare mock tables, figures, and listings
- Review programming specifications and work with statistical analysts/programmers to prepare CDISC compliant SDTM and ADaM datasets
- Conduct inferential statistical analyses and check model adequacy of statistical analyses
- Perform statistical validation/quality control on analyses generated by statistical analysts/programmers
- Conduct ad-hoc analyses and data mining
- Write statistical reports for results interpretation if needed
- Participate in clinical results interpretation meetings
- Work with medical writers to assist with clinical study reports preparation
- Work with project managers to ensure timely and high quality delivery of analysis packages
Qualifications
Education
- Master’s in statistics or biostatistics
Experience
Master’s degree with 0-2 years of relevant experience in statistical analyses
Skills
- Good understanding in statistical concepts and methods
- Working knowledge of SAS and/or R
- Good interpersonal and communication skills
WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by February 9, 2022 or undergo weekly COVID-19 testing as set forth in WuXi AppTec’s Mandatory COVID-19 Vaccination Policy, unless they are eligible for an exemption from the vaccination or testing requirements based on a disability or sincerely held religious belief, practice or observance. If you are offered employment with WuXi AppTec, you will be required to provide acceptable proof of your COVID-19 vaccine (if applicable) no later than 8 days before your first day of employment
This document is intended to describe the general content and to identify essential functions and requirements for performing this job, and it is not an exhaustive statement of duties, responsibilities or requirements.
Pharmapace, Inc. complies with the ADAAA and considers reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential job functions