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Clinical Trials Lead Programmer

hace 2 meses

Barcelona, Barcelona, España Mygwork A tiempo completo

About the Role

We are seeking a highly experienced and motivated Clinical Trials Lead Programmer to join our dynamic team at Mygwork, an inclusive employer and a member of the LGBTQ+ business community.

Key Responsibilities

  • Oversee the statistical and programming aspects of multiple projects, acting as the lead programmer, project lead, or project oversight lead for a client/asset.
  • Play a crucial role in the design, analysis, and reporting of clinical trials, ensuring adherence to regulatory requirements and industry standards.
  • Represent the department to clients, actively contributing to proposals and bids, and organizing teams to implement study strategies and ensure process and programming efficiencies.
  • Manage a small team within the programming group, including interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
  • Approve courses of action on salary administration, hiring, corrective action, and terminations.
  • Review and approve time records, expense reports, requests for leave, and overtime.
  • Promote all aspects of Mygwork's Equal Employment Opportunity policy and Affirmative Action Plan.
  • Assure department adherence to good scientific, ethical, and regulatory standards.
  • Interpret and administer policies, processes, and procedures that may affect sections and subordinate work units.

Requirements

  • MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
  • Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 5 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
  • Experience Preferred is at least 6 years of clinical trial experience as a statistical programmer and at least 1 year of leadership experience.
  • Knowledge, Skills, Abilities: Programming experiences for the studies in Clinical Pharmacology is strongly preferred. Good knowledge and background in statistics are preferred. In-depth understanding and expert level knowledge of SAS or more programming languages. Expert level knowledge and highly resourceful hands-on experiences in SDTMS/ADaMs /TLFs specifications and programming. Good Knowledge of Pinnacle 21. Strong SAS programming skills and understanding of database structures. Strong organizational skills across individual projects. Capable of independently and effectively organizing and managing own and team work loads, and completing multiple assignments with challenging timelines. Ability to adapt and adjust to changing priorities. Excellent written and verbal communication skills, including proficiency in the English language. Capable of working in a multi-disciplinary team setting. Basic understanding of statistical principles applied to the design and analysis of clinical trials. Capable of contributing to the development of policies and making decisions regarding programming on company policies and procedures. Strong problem solving skills. Ability to supervise and mentor as shown by leadership of projects and team members. Strong attention to detail. Capable of facilitating communications with clients, project teams, departments and staff. Awareness for project budget creation, including modifying for project updates. Capable of managing project budgets and risks. Strong understanding of clinical trials, ICH Statistical and reporting guidelines and GCP.

What We Offer

  • Competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
  • Employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
  • An exciting company culture that stands for integrity, intensity, involvement, and innovation.
  • A Mission to enable our customers to make the world healthier, cleaner and safer.