Job Description

Our Medical Device client is seeking a Sr. Statistical Programmer Manager who will be a team driven leader to support two clinical trials about to go into submittal phase.

Sr. Statistical Programmer Manager
Duration: 6+ months, W-2
Location: Remote - Must travel onsite to Irvine, CA 1x per quarter.
Pay: $80/hr - $87/hr

Apply if you have:

• Expert level SAAS programming skills - Macros specifically
• Prior work leading a team in the submission phase with the FDA, DEKRA, or PDMA (Japan FDA equivalent)
• Proven track record of leading a team to meet deadlines in the pharmaceutical or med device field
• Experience with R programming
• Any FDA clinical trial submission technology experience

Duties:

• Manage and oversee the work of a small team of statistical programmers and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department
• Provide programming expertise on multiple clinical trials for analysis for inclusion in clinical study reports, presentations, or select publications in collaboration with project statistician
• Provide programming expertise on complex ad hoc data requests in collaboration with project statistician
• Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties
• Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review
• Lead a team of programmers in collaboration with cross-functional teams to ensure that database and external data source when applicable meet analysis requirements across clinical trials
• Develop and revise statistical programming procedures or instructions

Skills and Experience:

• Bachelor's Degree and a minimum of 8 years' experience in statistical analysis OR Master's degree requires 5 years' experience OR PhD requires 2 years' experience
• Experience working in clinical trials and preparing study submissions
• Previous people leader experience
• Proven successful project management leadership skills
• Expertise in SAS and Windows operating systems
• Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
To apply please email your resume to ctack@rothstaffing.com

Job Snapshot

• Employee Type:Full-Time
• Location:Home-Based, CA
• Job Type:Biotech, I.T.
• Experience:Not Specified
• Education:Not Specified
• Date Posted:5/25/2023
• Contact: Cristina Tack (949) 265-6070
• Pay Range: $80.00 - $86.00 Hourly

Get Job Alertsby Email

• Receive alerts with new job opportunities that match your interests
• Receive relevant communications and updates from our organization

Sign Up Now