Statistical Programming Manager (Full Time, 100% Remote) - Elan Solutions : Job Details

Job Description:Title: Manager, Statistical Programming Manager (Full Time, 100% Remote)Client: CROLocation: Remote (Bay Area) Salary Range: $150,000 - $153,800 Must Have:

CRO experience of 5+ years

Study Lead experience of 3+ years

Personnel Management experience of 3+ years

Work in Pacific Time Zone (8 hours in an East to West coast time frame)

Diverse therapeutic areas experience

Excellent oral and written communication

Overview: We are seeking a Statistical Programming Manager with extensive CRO and clinical experience for a CRO client, located in the Bay Area. Ideal candidate will be a highly motivated and detail-oriented professional. Please reach out to us if you experience matches below Responsibilities:

• Act as the lead for statistical programming on products and/or groups of studies, serving as the main contact for all programmer communications and overseeing task assignments.
• Independently support statisticians in planned and ad hoc analyses, showcasing SAS programming proficiency.
• Write and execute statistical programs to create analysis databases, tables, listings, and figures for clinical trial reports.
• Oversee programming resources across multiple studies, serving as a key resource for other statistical programming leads.
• Offer timely support to study teams on programming matters according to project strategies, ensuring the integrity of data and on-time deliverables.
• Execute programming and project standards to support the production or validation of CDISC SDTM, ADaM datasets, and other deliverables.
• Ensure adherence to quality control procedures for all statistical programming activities.
• Assist in the development, implementation, maintenance, and testing/validation of the SAS macro library and other utility code/tools to improve statistical programming efficiency.
• Develop and maintain programming procedures to implement and standardize CDISC and other regulatory requirements.
• Engage in initiatives aimed at enhancing biostatistical programming processes.
• Contribute to the development of plans for biostatistical programming, including structure, workflow, standardization, productivity enhancement, and future development.
• Provide mentoring and support to other statistical programmers.
• Contribute to the development and maintenance of Standard Operating Procedures (SOPs) and training guidelines for statistical programming.
• Participate in internal study team and client meetings as required.

Education and Experience Requirements:

• Degree: B.S. or B.A. in computer science, statistics, or a related scientific discipline.
• Experience: Minimum of 12 years of SAS programming experience, with at least 6 experience handling clinical study data in a contract research organization or pharmaceutical/biotech company.

Knowledge & Skill Requirements:

• Advanced knowledge of SAS Base, SAS Stat, SAS Macro, and SAS Graph.
• Proficient in CDISC standards and regulatory submission requirements.
• Familiarity with other programming languages such as R or Python is a plus.
• Demonstrated experience in preparing, processing, and analyzing clinical data through SAS code or macros.
• Experience across all phases of studies, including submissions.
• Exposure to multiple therapeutic areas and indications.
• Ability to process clinical data required for statistical analysis and support the creation of summary tables, data listings, graphs, and CDISC datasets for regulatory submission.
• Minimum of 4 years of personnel management experience.
• Capability to manage multiple projects with competing and stringent deadlines.
• Excellent oral and written communication skills.
• Ability to work effectively in a collaborative and multidisciplinary environment.

Required Skills: • Personnel Management • Graphs • SAS • Regulatory Requirements • Salary • Mentoring • Validation • Programming Languages • Deliverables • R • Statistics • Quality Control • Programming • Databases • Computer Science • Education • Research • Python • Testing • Maintenance • Communication • Science • Training • Management