Statistical Programmer

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.

Summary of Job Responsibilities:

As member of the Biostatistics and Data Management (PBS) department, and reporting to the Global Head of Statistical Programming or to the local manager (Director / Associate Director of statistical programming), the main responsibilities of the Principal Statistical Programmer will be to:

Provide leadership in promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives.

Lead, or contribute to, statistical programming activities on PBS projects (development or QC of deliverables):

delivering exemplary perfrmance and solving complex technical problems to inspire other programmers,

ensuring an efficient cllaboration with PBS teams in Europe and India,

being accuntable for the quality, traceability, reproducibility and timeliness of statistical programming deliverables,

being accuntable for overall client satisfaction with these deliverables,

maintaining a detailed project and validation plan,

efficiently communicating with internal and external clients,

and ensuring budget monitoring and adherence

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

Clinical study reprting, 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

Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…)

Understand, follow and ensure adherence to all PBS SOPs as well as any other relevant SOPs.

Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation

When needed, interact with regulatory agencies regarding specifications for electronic submissions, and direct/develop statistical programming electronic submission deliverables.

Occasionally, responsibilities will also include to:

Contribute to the development of a strong team of statistical programmers in the US, by functionally managing local programmers with respect to statistical programming strategy, deliverables, processes, and professional development

Contribute to budget evaluation for proposal writing purpose.

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.

Qualifications and Experience:

Minimum Education: BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics)

Minimum Work Requirements:

Preferably at least 10 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development

Consistent experience as a lead statistical programmer on several concurrent projects

Proficient in SAS

Strong knowledge of CDISC ADaM and SDTM.

Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.

Strong knowledge of relevant regulatory and data submission guidelines..

Strong project management skills

Skills:

Fluent in English (French and/r German is a plus)

Ability to work effectively in international teams, effectively operates within a matrix organization and with multi-disciplinary groups, excellent team player with strong interpersonal skills contributing to building the team spirit

Ability to rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries

Ability to organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills

Ability to educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements

Strong mentoring skills

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.