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Sr Manager CDM Programming

Thermo Fisher Scientific • Full-time • Remote (India) • 1w ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

Manages a small team within the department who are responsible for the bioinformatics programming aspects of clinical trials from design through analysis and reporting. Acts as the lead programmer, project lead, or project oversight lead of a client/asset on multiple projects, able to oversee both the statistical as well as programming aspects of clinical trials from design through analysis and reporting.
Represents the department to clients on study matters, bid defenses or submission of clinical data to regulatory authorities, directly contributing to proposals and bids, organizing teams and implementing study strategies to ensure process and programming efficiencies, and the creation and maintenance of programs for statistical report generation, and program validation.

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 scale. In 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.
Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.

Qualifications:
Education and Experience:

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

Knowledge, Skills and Abilities:

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