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