Statistical Programming Manager - Elan Solutions LLC

Title: Manager, Statistical Programming Manager (Full Time, 100% Remote)

Client: CRO

Location: Remote (Bay Area)

Salary Range: $150,000 - $153,800

Must Have:

1. CRO experience of 5+ years

2. Study Lead experience of 3+ years

3. Personnel Management experience of 3+ years

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

5. Diverse therapeutic areas experience

6. 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.