Principal Statistical Programmer
Company: Cytel Inc
Posted on: June 9, 2021
Cytel provides unrivaled
biostatistics and operations research knowledge to our customers in
the life sciences industries in the form of both software and
services. At Cytel, we work hard to create successful careers
with significant professional growth for our employees, as a result
of which they work hard to make Cytel successful. Cytel is a place
where talent, experience and integrity come together to advance the
state of clinical
Statistical Programmer has the following
- Lead programmer and
primary point of contact for a clinical trial
- Provides significant
technical expertise for statistical programming, development of
automated reports and preparation of submission data standard
- Participates in all
phases of programming support.
- Supports statistical
programming activities for multiple and/or large/complex
drug/vaccine clinical development projects.
predominantly includes the development and execution of statistical
analysis and reporting deliverables (e.g. safety and efficacy
analysis datasets, tables, listings, figures).
- Responsible for the
design and maintenance of statistical datasets that support
multiple stakeholder groups.
- Key collaborator with
statistics and other project stakeholders in ensuring that project
plans are executed efficiently with timely and high quality
- May serve as the
statistical programming point of contact and knowledge holder
through the entire product lifecycle for the assigned
- Effective analysis and
report programming development and validation utilizing global and
TA standards and following departmental SOPs and good programming
- Maintain and manage a
project plan including resource forecasting.
- Coordinate the
activities of the supplier’s programming team; interacts with Merck
- Strong project
management skills; leadership at a protocol level; determines
approach and ensures consistency and directs development of others
when opportunities arise; ability to engage key
- Designs and develops
complex programming algorithms.
- Ability to comprehend
analysis plans which may describe methodology to be programmed; an
understanding of statistical terminology and
- Expertise in CDISC and
- Master's degree,
preferably in a scientific discipline such as Statistics, Computer
Science, Mathematics, etc.
- 7+ years of SAS
programming experience in the Pharmaceutical & Biotech
- Strong SAS data
manipulation, analysis and reporting skills- with strong output
- Very good experience in writing and reviewing programming
- 2 years of study lead
experience, preferably juggling multiple projects simultaneously
- Ability to implement the
latest CDISC SDTM / ADaM standards
- Strong ADaM experience,
which includes pooling of datasets for ISS
- Totally familiar with Define.xml and reviewers guide
- Strong Knowledge of statistics
- Very good knowledge on e-submission preparation is strongly
- Ability to provide solutions for complex programming issues
(includig creation of complex macros), presenting alternatives and
identifying best solution.
- R-programming experience is preferred.
Keywords: Cytel Inc, Canton , Principal Statistical Programmer, Other , Canton, Michigan
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