Associate Director, Statistical Programmer EU
Company: Cytel Inc
Location: Durham
Posted on: June 12, 2021
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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: 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, Durham , Associate Director, Statistical Programmer EU, Other , Durham, North Carolina
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