Senior Statistical Programmer - SDTM team (Contractor)

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 Senior 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

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

• Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of project requirements, scope of work and timelines.

• 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.

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

• 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, R, Python) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

• 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.

• Lead statistical programming activities for assigned projects, which will include projects expected to be submitted to regulatory authorities and may include pooling projects (ISS/ISE).

What You Offer

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
• 6+ years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.
• Study lead experience working with cross functional teams, including leading programming teams.
• Fluent in English.
• Proficient in SAS,
• Project management, organizational skills, ability to manage competing priorities, and flexibility to change.
• Good understanding of drug development process, including knowledge of interfaces and interdependencies with other functions.
• Good time management and interpersonal 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.

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.