Clinical Trials Lead Programmer

hace 2 semanas

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. In this role, you will be responsible for overseeing the statistical and programming aspects of multiple projects, acting as the lead programmer, project lead, or project oversight lead for a client/asset.

Key Responsibilities

  • Serves as a lead programmer or project lead on selected studies or drug programs of all complexity and size scale.
  • Works directly with teams and clients to conduct team meetings, develop and maintain project timelines, assess and forecast resources needed, and is accountable for study budgets and familiar with any relevant contractual obligations or limits with our clients.
  • May serve in a senior project oversight role on selected projects.
  • May serve in a contributor or reviewer role of key submission materials for regulatory authorities.
  • Provides general infrastructure support to the department, including representing the company at industry conferences, presenting/teaching at department meetings, establishing training materials for the department, contributing to documents or policies, and contributing to process improvement and department initiatives.
  • Increases knowledge base and professional skills for self and junior team members, in areas including programming technology and techniques, clinical trials, and developments in the pharmaceutical industry.
  • Works to increase the visibility of the company by encouraging the publication of articles in industry journals and presentations at conferences.
  • May manage staff of small team, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
  • Approves courses of action on salary administration, hiring, corrective action, and terminations.
  • Reviews and approves time records, expense reports, requests for leave, and overtime.
  • Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan.
  • Assures department adherence to good scientific, ethical, and regulatory standards.
  • Interprets and administers 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, or 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.
  • Preferred is at least 6 years of clinical trial experience as a statistical programmer and at least 1 year of leadership experience.
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Preferred Skills

  • 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.
  • Delivery and quality driven.

What We Offer

  • We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
  • Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
  • We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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