Senior Statistical Programmer

Company: Cytel Inc
Location: New Haven
Posted on: June 9, 2021

Job Description:

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 development.

The Principal Statistical Programmer will work directly with the stakeholders to lead statistical programming projects and to ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements. The Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets and will ensure audit readiness for all tasks. The Principal Statistical Programmer will provide mentoring and training to statistical programming staff members. They may contribute to the development of the department by being involved in the recruitment process and in the design of new statistical programming processes or optimization of existing ones. 

JOB RESPONSIBILITIES:  

• Lead statistical programming activities for assigned projects, which could include Pooling projects (e.g. ISS/ISE) expected to be submitted to regulatory authorities.  

• Co-ordinate activities of all programmers assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget.  

• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.  

• Provide relevant training and mentorship to staff and project teams on SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements. 

• Utilizing project management skills to serve as key collaborator with project stakeholders in ensuring appropriate understanding of project requirements, scope of work and timelines. determining approach and ensuring consistency when opportunities arise. 

• Occasionally, being able to serve as statistical programming point of contact and knowledge holder through the entire product lifecycle for the assigned protocols if/when called upon. 

• May act as a line manager by functionaly managing and guiding the programmers with respect to statistical programming strategy, deliverables, processes, and professional development. 

• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:  

• clinical study reporting, e.g. ICH E3, 

• electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11,  

• electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards. 

• Understand and follow all relevant standard operating procedures (SOPs). 

• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation. Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. 

• May contribute to the development of the department by being involved in the recruitment process. 

• Occasionally, lead, or contribute to, the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to reach the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness. 

• Occasionally, represent the programming department during audit. 

QUALIFICATIONS:  

Education:  BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics). Master’s Degree preferred. 

Experience:  

• 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with excellent knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.  

• Experience as a lead statistical programmer working with global cross functional teams for at least 5 years is required. 

Skills:  

• Fluent in English.  

• Proficient in SAS programming, R or Python programming skills a plus. 

• Strong project management, organizational skills, ability to manage competing priorities, and flexibility to change. 

• Excellent time management, mentoring, interpersonal and conflict resolution skills,  

• Written/verbal communication and presentation skills are needed along with the ability to establish and maintain effective working relationships with coworkers, managers and clients. 

• Good knowledge of the pharmaceutical industry including understanding of clinical drug development process and data submission guidelines. 

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, New Haven , Senior Statistical Programmer, Other , New Haven, Connecticut