Principal Statistical Programmer - Oncology
Company: Cytel Inc
Posted on: June 9, 2021
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
We are experiencing exponential growth on a global scale
and hiring a Senior 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
Associate Director, Statistical Programming.
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 supplier’s 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
- 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 following SOPs .
What you offer:
- Bachelor’s degree or equivalent, preferably in a
scientific discipline such as Statistics, Computer Science,
- Minimum 10 years of SAS programming experience
supporting clinical trials in the Pharmaceutical & Biotech
- 5+ years of study lead experience working with
cross functional teams, including leading programming
- Minimum 3 years of recent experience supporting
- 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
- Strong proficiency implementing the latest CDISC
SDTM / ADaM standards.
- Familiarity with drug development life cycle and
experience with the manipulation, analysis and reporting of
clinical trials’ data.
- Submissions experience utilizing define.xml and
other submission documents.
- Excellent analytical & troubleshooting
- 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
- Our collaborative working
environment encourages innovation and rewards results, and we are
proud to have one of the lowest turnover rates in the
- In addition to a competitive
compensation, we offer an excellent benefit’s package, annual bonus
incentive, promote work-life balance, and the opportunity to grow
- Work with respected experts
and thought leaders in the fields of biostatistics and statistical
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 Cytel’s 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 Inc, Lancaster , Principal Statistical Programmer - Oncology, Other , Lancaster, Pennsylvania
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