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MANAGER STATISTICAL PROGRAMMING

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 

Offer summary

Qualifications:

Proficiency in SAS programming in clinical data environment, Understanding of clinical development and regulatory requirements, Bachelor's in Statistics, Computer Science or related field with 8+ years experience.

Key responsabilities:

  • Lead programming activities within therapeutic area(s)
  • Support quality programming deliverables in assigned projects
  • Act as technical resource for programming group
  • Support global regulatory authority submissions
  • Contribute towards department goals
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:
  • The Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s).
  • The incumbent will work with management and study team, plan and manage the implementation and execution of programming project standard to support from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety reports, and other requests.
  • Lead programming support within multiple studies/projects in various study activities to ensures timely and high-quality programming deliverables in assigned projects and areas. Coordinate programming documentations and specifications for multiple studies following programming standards and processes.
  • Demonstrate company values and act as a role model by demonstrating excellence, competence, collaboration, innovation, respect, ownership, and accountability.
  • Understand the scope of work, plan and complete the deliveries and timelines with the study team, programming lead and management.
  • Act as a technical resource for programming group to provide advice on complex programming tasks, standards, and process.
  • Support global regulatory authority submissions including preparing programming deliverable for submission and working closely with partnering functions to address health authority request.
  • Participate and contribute towards department goals and SME topics.

Requirements:

  • Proficiency in SAS programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as R, Python etc. is a plus.
  • Understanding of pharmaceutical clinical development across multiple therapeutic areas (i.e. understanding of statistical concepts, techniques and clinical trial principles) and good knowledge of regulatory submissions and requirements
  • Ability to work on global interdisciplinary teams.
  • Good organizational, interpersonal, communication, and leadership skills.
  • Establish and maintain effective working relationships with coworkers, managers, and clients.
  • Ability to effectively manage multiple tasks and projects.
  • Problem solving and innovative skills that demonstrate initiative and motivation.
  • Ability to influence others, mentor, and coach junior programmers to achieve results.
  • Bachelor's in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field with 8+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related industry.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Verbal Communication Skills
  • Organizational Skills
  • Motivational Skills
  • Open Mindset
  • Social Skills
  • Analytical Skills
  • Teamwork
  • Leadership Development
  • Mentorship

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