Principal Statistical Programmer

Company: Cytel Inc
Location: South Bend
Posted on: June 9, 2021

Job Description:

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 PBS 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.

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 packages.

·         Supporting statistical programming activities for multiple and/or large/complex drug/vaccine clinical development projects.

·         Development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures),

·         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 forecasting.

·         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 concepts.

·         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 integrated).

·         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, Mathematics, etc.
• 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 studies.    
• 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 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 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 benefit’s 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.

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 law.

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 businesses/agencies.

Keywords: Cytel Inc, South Bend , Principal Statistical Programmer, Other , South Bend, Indiana