Associate Director, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer statistical programming assistance for compounds at various stages of development, which includes clinical development, regulatory submissions, and commercialization.

• Act as the lead programmer for designated clinical trials.

• Collaborate with study statisticians, data management, and other functions within the study team.

• Review and verify the quality of Define packages, such as aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and Define XML.

• Assess Define packages for integrated datasets to ensure compliance with CDISC standards and regulatory submission criteria.

• Work alongside the study lead biostatistician to oversee vendor deliverables concerning quality and timelines.

• Conduct independent quality control validation of vendor deliverables, datasets, and analytical outputs.

• Validate analytical outputs generated by internal biostatisticians or statistical programmers.

• Create systematic data reports with Clinical Data Management to aid in clinical trial data review and cleansing.

• Examine CRFs and/or Data Transfer Specifications to confirm that data collection aligns with study objectives, requirements, and CDISC standards.

• Contribute to Statistical Analysis Plans and TLF shells for Tables, Listings, and Figures.

• Execute statistical analyses that support publications and regulatory communications.

• Carry out other assigned responsibilities.

⛳️ Requirements

• Master's Degree in Biostatistics, Statistics, Computer Science, or related fields.

• Minimum of 12 years of experience providing statistical programming support in a clinical trial environment.

• In-depth understanding of data standards.

• Extensive experience with Pinnacle 21 validation reports and the creation of Define XML packages for regulatory submissions.

• Proficient in SAS, including complex data steps, SAS macro languages, and commonly utilized analysis procedures such as PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED.

• Proven ability to collaborate with biostatisticians, Clinical Data Management, and colleagues from various functions.

• Strong organizational and project management capabilities.

• Demonstrated ability to manage multiple projects in a fast-paced setting.

• Detail-oriented with high standards for excellence in Statistical Programming deliverables.

• Capable of delivering and communicating effectively in a remote work environment.

• Excellent interpersonal skills and the ability to work well in a team setting.

• Preferred: experience in data structuring and analysis within CNS clinical trials.

• Preferred: experience in providing integrated data analysis support for regulatory submissions.

🏝️ Benefits

• Comprehensive health benefits, including Medical, Dental, and Vision coverage for you and your dependents, fully paid.

• 401(k) plan with company matching and vesting commencing after the first month from your start date.

• Flexible time-off policy.

• Generous parental leave.

• Various enjoyable fringe benefits.

• Additional compensation opportunities, including bonuses and equity, may be available.