Mgr CDM Programming

Work Schedule

Environmental Conditions

Job Description

Join Us as a Team Leader Programming Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in clinical trials. As a Team Leader Programming you will manage a small team within the department who are responsible for the bioinformatics programming aspects of clinical trials from design through analysis and reporting. You will act as the lead programmer project lead or project oversight lead of a client/asset on multiple projects overseeing both the statistical and programming aspects of clinical trials from design through analysis and reporting.
You will represent the department to clients on study matters bid defenses or submission of clinical data to regulatory authorities. You will directly contribute to proposals and bids organize teams and implement study strategies to ensure process and programming efficiencies. Additionally you will be responsible for the creation and maintenance of programs for statistical report generation and program validation.

What Youll Do:

Manages staff 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.
Serves as a lead programmer or project lead on selected studies or drug programs of all complexity and size these roles works directly with teams and clients to conduct team meetings develop and maintain project timelines assess and forecast resources needed 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. Examples include 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.

Education and Experience 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 Bachelors 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.

Knowledge Skills and Abilities:
Strong SAS programming skills EDC like Veeva vault Rave 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

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to electrical office equipment.
Occasional drives to site locations frequent domestic travel and rare international travel.
Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.