Associate Director, Statistical Programmer EU

Company: Cytel Inc
Location: Gaithersburg
Posted on: June 12, 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.

We are experiencing exponential growth on a global scale and hiring a Associate Director 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 Senior Director, Statistical Programming.

Summary of Job Responsibilities:

As member of the Project Based Services (PBS) division, and reporting to the Global Head, Statistical Programming or Local Director/Associate Director of Statistical Programming, the main responsibilities of the Associate Director Statistical Programming will be to:

• As a line manager, contribute to the development of a strong team of statistical programmers, by functionally managing and guiding the programmers with respect to statistical programming strategy, deliverables, processes, and professional development.

• Provide leadership in organizing teamwork, prioritizing and balancing concurrent tasks and responsibilities ensuring high quality, respecting timelines and adherence to the budget.

• Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers…) as well as SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.

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

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

• May contribute to process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

• May Lead, or contribute to the design of new statistical programming processes/systems or optimization of existing ones that streamline operations to increase statistical programming efficiency.

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

• Occasionally, contribute to budget evaluation for proposal writing purpose and be programming representative during bid-defense.

• As senior team member be the programming representative during audits.

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

• 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.

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)

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

• Preferably 2 years of experience as a statistical programming team leader or manager

• Consistent experience as a lead statistical programmer on several concurrent projects

• Proficient in SAS

• Good 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.

• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management.

• Strong project management skills

• Fluent in English (French and/or 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

• Good negotiation and issue resolution skills

• 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

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, Washington DC , Associate Director, Statistical Programmer EU, Other , Gaithersburg, DC