Principal Statistical Programmer - South Africa
Cytel Inc
vor 3 Tg.

As member of the Project Based Services (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 prject and validation plan,
  • efficiently cmmunicating with internal and external clients,
  • and ensuring budget mnitoring 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
  • Electrnic records handling, e.g. Chapter 21 of the US Code of Federal Regulation - Part 11
  • Electrnic 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 f experience in biostatistics or statistical programming activities in the Pharmaceutical / Biotechnology industry in clinical development
  • Cnsistent experience as a lead statistical programmer on several concurrent projects
  • Prficient in SAS
  • Strng knowledge of CDISC ADaM and SDTM.
  • Strng understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
  • Strng knowledge of relevant regulatory and data submission guidelines..
  • Strng project management skills
  • Skills :
  • Fluent in English (French and / r German is a plus)
  • Ability t 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 t rapidly understand and anticipate the needs of internal and external customers, and respond to their inquiries
  • Ability t organize team work and prioritize and balance concurrent tasks and responsibilities. Excellent time management skills
  • Ability t educate internal and external interfaces (providers and customers) on the statistical programming processes, and the underlying regulatory requirements
  • Strng 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.

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