Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Execute programming and statistical analyses essential for evaluating clinical trial outcomes and associated research findings.

• Aid in the interpretation of analytical results and supply statistical insights for reporting purposes.

• Validate and verify external CRO statistical programs along with the resulting Tables, Listings, and Graphs (TLGs).

• Engage in the development and upkeep of the SAS macro library and safety database.

• Collaborate with CROs to guarantee that analyses and outputs are precise and align with the agreed-upon deliverables.

• Identify and address data analysis challenges in conjunction with vendor staff.

• Generate statistical analyses in accordance with protocols and Statistical Analysis Plans (SAPs).

• Create statistical programs and outputs for comprehensive scientific reports.

• Offer statistical contributions for SAPs, publications, scientific presentations, and promotional materials.

• Review Case Report Forms (CRFs), CRF annotations, SAPs, TLG templates, and TLGs.

• Represent statistical programming during study team meetings and relay statistical concerns to development teams.

• Participate in the assessment, selection, and evaluation of CROs.

• Develop and review specifications for derived datasets and associated analysis datasets.

• Formulate statistical programming training guidelines.

⛳️ Requirements

• A Master’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) along with a minimum of 7 years of experience in statistics or statistical programming within a biotech/pharmaceutical or CRO setting.

• A Bachelor’s degree in a quantitative sciences discipline (e.g., Statistics, Mathematics, Computer Science) with at least 10 years of experience in statistics or statistical programming in a biotech/pharmaceutical or CRO environment.

• Proficient SAS programming skills (e.g., Base SAS, SAS/Stat, SAS/Graph, SAS macros, ODS) and a solid understanding of database systems.

• Experience leading programming initiatives involving CDISC SDTM, ADaM, and eSubmission (e.g., define.xml, ADRG/SDRG).

• Practical knowledge of clinical data analysis and reporting processes as they pertain to drug development.

• Strong interpersonal and communication skills.

• Well-organized with the capacity to adapt to shifting priorities.

• Experience collaborating with CROs.

• Experience with NDA/MAA submissions.

🏝️ Benefits

• Equity and other compensation options may be included as part of the overall compensation package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 401k plan.

• Unlimited paid time off.

• Parental leave.

• Remote work opportunities.

• A dynamic, interactive, fast-paced, and entrepreneurial work environment.