Principal Statistical Programmer - Oncology
Company: Cytel Software Corporation
Location: Port Saint Lucie
Posted on: September 16, 2022
Cytel is shaping the future of drug development. As the world's
largest independent clinical biostatistics research and development
organization, we help leading pharmaceutical, biotech and medical
device companies improve clinical success rates via optimal study
design, effective data management, accurate statistical analysis
and software. With operations across North America, Europe, and
India, we are always on the lookout for passionate and talented
people who share our mission of ensuring the clinical development
of safe and effective medicines. We are experiencing exponential
growth on a global scale and hiring a Principal Statistical
Programmer to join our FSP division. You will exercise your strong
communication and leadership skills to support or lead one or more
clinical trials, across various therapeutic areas. You will report
to the Director, Statistical Programming. For this role we are
looking for candidates with existing experience in oncology
clinical trials who ideally have also used R as well as SAS in
their work.You will contribute by:
- Providing significant technical expertise for statistical
programming in all phases of programming support, developing
automated reports and preparation of submission data standard
- Supporting statistical programming activities for multiple
and/or large/complex drug/vaccine clinical development
- Development and execution of statistical analysis and reporting
deliverables (e.g. safety and efficacy analysis datasets, tables,
- Design and maintenance of statistical datasets that support
multiple stakeholder groups.
- Serving as key collaborator with statistics and other project
stakeholders in ensuring that project plans are executed
efficiently with timely and high quality deliverables.
- Being able to serve as statistical programming point of contact
and knowledge holder through the entire product lifecycle for the
assigned protocol if/when called upon.
- Effective analysis and report programming development and
validation utilizing global and TA standards and following
departmental SOPs and good programming practices.
- Maintaining and managing a project plan including resource
- Coordinating the activities of the suppliers programming team;
and interacting with client statistical programmers
- Utilizing strong project management skills and ability to
engage key stakeholders; leadership at a protocol level;
determining approach and ensuring consistency, and directing
development of others when opportunities arise.
- Designing and developing complex programming algorithms.
- Comprehending analysis plans which may describe methodology to
be programmed; an understanding of statistical terminology and
- Utilizing expertise in CDISC and ADaM standards.
- Statistical programming for early and late stage clinical
trials which can include both planned and ad-hoc needs.
- Enriched / Post Processed Datasets (individual or
- ADaM datasets (individual or integrated)
- Protocol and therapeutic area specific tables, listings, and
figures (individual or integrated).
- Programming documentation followingSOPs .What you offer:
- Bachelors degree or equivalent, preferably in a scientific
discipline such as Statistics, Computer Science, Mathematics,
- Minimum 10 years of SAS programming experience supporting
clinical trials in the Pharmaceutical & Biotech industry.
- 5+ years of study lead experience working with cross functional
teams, including leading programming teams.
- Minimum 3 years of recent experience supporting Oncology
- Strong experience in QCing and validating work of other
programmers, preferably outsourced work.
- Strong SAS data manipulation, analysis and reporting skills-
with strong output programming experience
- Strong proficiency implementing the latest CDISC SDTM / ADaM
- Familiarity with drug development life cycle and experience
with the manipulation, analysis and reporting of clinical trials
- Submissions experience utilizing define.xml and other
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in
adherence with challenging timelines.
- Ability to work effectively and successfully in a globally
dispersed team environment with cross-cultural partners. Why Cytel?
Our collaborative working environment
encourages innovation and rewards results, and we are proud to have
one of the lowest turnover rates in the industry. In addition to a
competitive compensation, we offer an excellent benefits package,
annual bonus incentive, promote work-life balance, and the
opportunity to grow with us!Work with respected experts and thought
leaders in the fields of biostatistics and statistical programming.
#LI-AP1#CYTELNA#CYTELINT Cytel Inc. is an Equal Employment /
Affirmative Action Employer. Applicants are considered for all
positions without regard to race, color, religion, sex, national
origin, age, veteran status, disability, sexual orientation, gender
identity or expression, or any other characteristics protected by
Cytel does not accept referrals from employment businesses and/or
employment agencies in respect of the vacancies posted on this
site. All employment businesses/agencies are required to contact
Cytels human resources department to obtain prior written
authorization before referring any candidates to Cytel. The
obtaining of prior written authorization is a condition precedent
to any agreement (verbal or written) between the employment
business/ agency and Cytel. In the absence of such written
authorization being obtained any actions undertaken by the
employment business/agency shall be deemed to have been performed
without the consent or contractual agreement of Cytel. Cytel shall
therefore not be liable for any fees arising from such actions or
any fees arising from any referrals by employment
Keywords: Cytel Software Corporation, Port St. Lucie , Principal Statistical Programmer - Oncology, Other , Port Saint Lucie, Florida
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