Director, Statistical Programming

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

📋 Description

• Oversee a team of statistical programmers to deliver programming assistance for designated projects, encompassing dataset creation (or validation) through to data analysis.

• Join the regulatory submission team as the lead statistical programmer to facilitate integrated data analyses and ensure compliance with all data prerequisites for regulatory submissions.

• Accountable for producing high-quality analysis datasets (SDTM and ADaM) that meet CDISC standards, while ensuring the precision of all derived variables for assigned clinical trials or integrated databases.

• Tasked with delivering high-quality integrated databases to support comprehensive safety and efficacy analyses.

• Responsible for creating high-quality DEFINE packages for SDTM and ADaM for either assigned clinical trials or integrated databases.

• Collaborate closely with biostatisticians to oversee vendor deliverables, ensuring quality and adherence to timelines.

• Conduct statistical data analysis using personal SAS programs as needed to aid in decision-making, regulatory communication, or drug product commercialization.

• Execute independent validation using personal SAS programs to confirm the accuracy of statistical vendor deliverables.

• Engage in the development of necessary SOPs or processes governing statistical programming activities.

⛳️ Requirements

• Master's Degree in Biostatistics, Statistics, Computer Science, or related fields, with a minimum of 15 years of experience in utilizing statistical programming to support clinical trial data analysis within the pharmaceutical, biotech, or CRO sectors.

• Extensive experience in building and leading statistical programming teams to deliver across multiple programs, often with conflicting priorities.

• In-depth knowledge of data standards and a solid understanding of creating DEFINE packages to facilitate regulatory submissions.

• Proficient in statistical computational software such as SAS, including complex data steps, SAS macro languages, and commonly utilized analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED).

• Significant experience in managing statistical vendors to ensure timely delivery with quality results and within budget constraints.

• Strong organizational, project management, and resource management skills.

• Detail-oriented with high standards of excellence for the deliverables produced by the Statistical Programming group.

• Ability to communicate and deliver effectively in a work-from-home environment.

• Proven track record in problem-solving, demonstrating a commitment to ongoing learning and professional growth.

• Excellent interpersonal skills and a collaborative team player.

• Preferred Experience: Background in providing statistical programming support for CNS clinical trials.

• Experience in providing statistical programming support for regulatory submissions.

🏝️ Benefits

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

• 401(k) plan with company matching and vesting beginning after the first month of employment.

• Flexible time off policy.

• Generous parental leave and some enjoyable additional perks!