Clinical SAS programmer

JOB description

A
minimum of 4 years of total experience with a at least 2 years of experience in
Statistical programming and/or design and analysis of Phase I to Phase IV
clinical trials in a Contract Research Organization or Pharmaceutical or
Biotechnology company

·         Thorough knowledge of the pharmaceutical
industry including understanding of clinical drug development process and
associated documents and regulations.

·         Good
knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other
regulatory guidance documents (e.g. USFDA and EMEA)

·         Understanding
client’s requirement and providing all the required statistical inputs on, SAP,
Mock Shells, Tables, Listings, Figures or any other statistical programming deliveries

·         Good understanding of the statistical
programming domain and related processes

·         Assists with developing, monitoring, and
enforcing productivity and quality standards along with related
documentations

·         Coordinating with the project management in
meeting the timeline and defining/ capturing the metrics for monitoring and
maintaining the quality and productivity

·         Good verbal and written communication skills
coupled with good organizational skills

Technical:

·         Strong
Analytical and programming Skills using statistical software SAS or equivalent
with understanding of development and/or execution of SAS macros

·         Knowledge
of R will be an added advantage

·         Should
have worked on generating and validating tables, listings and figures

·         Should
have worked on Derived datasets/Analysis Datasets/ADaM/SDTM

·         More
complex review (programs with high risk)

·         Programming
and review of outputs for DSUR,PSUR, publications

·         Exposure
on Exploratory analyses is an added advantage

·         Programming
and review of analysis data sets.

·         Provide
training and guidance to lower level and
new staff.

·         Experience
in submission packages (Define.xml, SDRG, ADRG, P21 reports)

Compliance:

•     Adherence to SOPs and GPP

·         Quality
and adherence to timelines.

·         Self-motivation
and self-learning

·         Achievement
orientation

·         Relationship
building ability

·         Inclination
towards being process driven