Lead Statistical Programmer

il y a 4 semaines

Paris, Île-de-France Cytel Temps plein
Lead Statistical Programmer (EU Permanent)

Cytel is at the forefront of transforming drug development. As the premier independent clinical biostatistics research and development organization globally, we assist top pharmaceutical, biotech, and medical device firms in enhancing clinical success rates through optimal study design, efficient data management, precise statistical analysis, and innovative software solutions. With a presence in North America, Europe, and India, we are continuously seeking dedicated and skilled individuals who align with our mission of facilitating the clinical development of safe and effective medicines.

Our rapid global expansion has created an opportunity for a Lead Statistical Programmer to join our PBS division. In this role, you will leverage your exceptional communication and leadership abilities to support or oversee multiple clinical trials across various therapeutic areas. You will report directly to the Director of Statistical Programming.

Key Responsibilities:

  • Delivering substantial technical expertise in statistical programming throughout all phases of programming support, including the development of automated reports and preparation of submission data standard packages.
  • Supporting statistical programming efforts for multiple and/or large-scale complex drug/vaccine clinical development projects.
  • Developing and executing statistical analysis and reporting deliverables, such as safety and efficacy analysis datasets, tables, listings, and figures.
  • Designing and maintaining statistical datasets that cater to various stakeholder groups.
  • Collaborating closely with statistics and other project stakeholders to ensure efficient execution of project plans with timely and high-quality deliverables.
  • Acting as the statistical programming point of contact and knowledge holder throughout the entire product lifecycle for the assigned protocol when required.
  • Conducting effective analysis and report programming development and validation, adhering to global and therapeutic area standards, departmental SOPs, and best programming practices.
  • Managing a project plan, including resource forecasting.
  • Coordinating the activities of the supplier's programming team and engaging with client statistical programmers.
  • Utilizing strong project management skills to engage key stakeholders, providing leadership at the protocol level, determining approaches, ensuring consistency, and guiding the development of others when opportunities arise.
  • Designing and developing intricate programming algorithms.
  • Understanding analysis plans that may describe methodologies to be programmed, along with a solid grasp of statistical terminology and concepts.
  • Applying expertise in CDISC and ADaM standards.
  • Performing statistical programming for both early and late-stage clinical trials, addressing both planned and ad-hoc needs.
  • Creating enriched or post-processed datasets (individual or integrated).
  • Generating ADaM datasets (individual or integrated).
  • Producing protocol and therapeutic area-specific tables, listings, and figures (individual or integrated).
  • Documenting programming activities in accordance with SOPs.

Qualifications:

  • Bachelor's degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • A minimum of 6 years of experience in biostatistics or statistical programming within the Pharmaceutical/Biotechnology industry, with a strong understanding of CDISC ADaM and SDTM, as well as ICH Statistical and Clinical Report Guidelines.
  • Experience leading studies while collaborating with cross-functional teams, including managing programming teams.
  • Extensive experience in quality checking and validating the work of other programmers, particularly outsourced work.
  • Proficient in SAS data manipulation, analysis, and reporting, with significant output programming experience.
  • Strong knowledge of the latest CDISC SDTM / ADaM standards.
  • Familiarity with the drug development lifecycle and experience in manipulating, analyzing, and reporting clinical trial data.
  • Experience with submissions and related documentation.
  • Excellent analytical and troubleshooting capabilities.
  • Ability to deliver high-quality outputs and deliverables while adhering to demanding timelines.
  • Proven ability to work effectively in a globally dispersed team environment with cross-cultural partners.

Why Choose Cytel?

  • Our collaborative work environment fosters innovation and rewards results, contributing to one of the lowest turnover rates in the industry.
  • We offer competitive compensation, an excellent benefits package, annual bonus incentives, promote work-life balance, and opportunities for professional growth.
  • Collaborate with respected experts and thought leaders in biostatistics and statistical programming.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. We consider applicants 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.

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