Senior / Principle Statistical Programmer

Clinovo

3-5 years

Not Disclosed

Remote

10 July 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Overview:

Clinovo’s mission is to empower healthcare and life science companies by providing expertise in sourcing and placing top clinical research professionals across a multitude of diverse opportunities. Clinovo has a proven track record with pharmaceutical, biotechnology, diagnostic, medical device, and CRO customers. Leading companies have chosen Clinovo as their preferred partner for its quality of customer service, excellent candidate profile, and long-term relationships.

Job Summary:

Our valued client is currently seeking a highly skilled and motivated Biostatistician with technical expertise to develop a process methodology for the department to meet internal and external clients’ needs. You will plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Additionally, you will provide technical expertise and leadership to the department and internal consulting services, including specifications and user needs analysis for complex projects or client requirements.

Key Responsibilities:

Programming and Documentation:
- Perform, plan, coordinate, and implement the programming, testing, and documentation of statistical programs for complex studies.
- Program analysis datasets (derived datasets) and transfer files for internal and external clients.
- Conduct programming quality control checks for source data and report data issues periodically.
Project Management:
- Interpret project-level requirements and develop programming specifications for complex studies.
- Provide advanced technical expertise to internal and external clients and bring project solutions to SP teams and the Statistical Programming department.
- Fulfill project responsibilities as a technical team lead for single complex studies or groups of studies.
- Estimate programming scope of work, manage resource assignments, communicate project status, and negotiate/re-negotiate project timelines for deliverables.
- Use and promote established standards, SOPs, and best practices.
Communication and Collaboration:
- Communicate directly with internal and client statisticians and clinical team members to ensure understanding of requirements and project timelines.
- Provide training and mentoring to SP team members and Statistical Programming department staff.

Preferred Skills and Experience:

Statistical Programming:
- Experience in statistical programming in SAS within the CRO/Pharmaceutical/Biotechnology/Healthcare industries.
- Advanced knowledge of Base SAS, SAS/STAT, SAS Graph, and SAS Macro Language.
Regulatory Knowledge:
- In-depth knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Project Leadership:
- Experience as a technical team lead, directly engaging clients and coordinating tasks within a programming team.
- Ability to lead teams and projects and manage at a group level.
Technical Skills:
- Knowledge of statistics, programming, and/or the clinical drug development process.
- Ability to independently manage multiple tasks and projects.
- Excellent accuracy and attention to detail.
- Ability to delegate work to other members of the SP team.
- Exhibits routine and occasionally complex problem-solving skills.
- Recognizes when negotiating skills are needed and seeks assistance.
Interpersonal Skills:
- Good organizational, interpersonal, leadership, and communication skills.
- Ability to establish and maintain effective working relationships with co-workers, managers, and clients.

Requirements:

Education and Experience:
- Master’s degree in computer science or a related field with 3 years of relevant experience.
- Bachelor’s degree or educational equivalent in computer science or a related field with 5 years of relevant experience.
- Equivalent combination of education, training, and experience may be considered.

Additional Information:

Location: Remote Role
Compensation: The compensation offered to the final candidate will depend on relevant work experience, skills, and years of experience.

Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.

Join Clinovo’s team and contribute to advancing clinical research through your expertise in biostatistics.

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Senior / Principle Statistical Programmer

Job Description

Company Overview:

Job Summary:

Key Responsibilities:

Preferred Skills and Experience:

Requirements:

Additional Information:

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