Analysis Oversight Statistical Programming Lead- Manager

Scorpion Therapeutics; Parsippany-Troy Hills (NJ); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Company-sponsored medical, dental, and

Vision and life insurance

Job summary

Scorpion Therapeutics seeks an Analysis Oversight Statistical Programming Lead to guide statistical programmers and influence decisions across studies. You will attend SMT meetings, review programming requirements, and ensure quality control per CDISC standards. Strong leadership and ADaM/TFL experience are essential.

You will coordinate with biostatisticians, vendors, and stakeholders to manage timelines, risks, and documentation while upholding regulatory expectations and data integrity.

Qualifications

• Bachelor’s degree with 7 years’ experience OR Master’s degree with 5 years’ experience.
• Experience leading studies in Virology, Oncology, or Inflammation Therapeutic Area preferred.
• Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.

Responsibilities

• Exhibit strong statistical & programming knowledge to influence key decisions and guide statistical programmers.
• Attend SMT meetings; provide input on programming activities, risks, and actions.
• Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
• Communicate SMT decisions to programmers; review and approve key study documents.
• Help programmers understand critical study documents; review and negotiate programming timelines.
• Participate in internal/external audits; identify opportunities to refine/simplify procedures.
• Analyze vendor performance using KPIs/KQIs and participate in governance discussions.
• Ensure adequate statistical programming resourcing; assign tasks based on experience/ability.
• Track programming activities in task management system; maintain milestone communications with stakeholders.
• Influence/support data and submission standards and templates.
• Perform quality checks to ensure complete/accurate deliverables compliant with Gilead and CDISC standards.
• Surface needs for new/updated standards; provide prioritization decisions and coaching.
• Ensure issues are logged and resolved prior to final production release.
• Hold analysis team meetings with biostatisticians; serve as point-of-contact with vendors/other functions.

Skills

Statistical programming

Team leadership

ADaM development

GCP/ICH knowledge

Data analysis

PK/PD programming

Education

Bachelor’s degree

Master’s degree

Job description

Analysis Oversight Statistical Programming Lead

Key Responsibilities (including, but not limited to):

• Exhibit strong statistical & programming knowledge to influence key decisions and guide statistical programmers.
• Attend Study Management Team (SMT) meetings; provide input on programming activities, risks, and actions.
• Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications).
• Communicate SMT decisions to programmers; review and approve key study documents.
• Help programmers understand critical study documents; review and negotiate programming timelines.
• Participate in internal/external audits; identify opportunities to refine/simplify procedures.
• Analyze vendor performance using KPIs/KQIs and participate in governance discussions.
• Ensure adequate statistical programming resourcing; assign tasks based on experience/ability.
• Track programming activities in task management system; maintain milestone communications with stakeholders.
• Influence/ support data and submission standards and templates.
• Perform quality checks to ensure complete/accurate deliverables compliant with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements).
• Surface needs for new/updated standards; provide prioritization decisions and coaching.
• Ensure issues are logged and resolved prior to final production release.
• Hold analysis team meetings with biostatisticians; serve as point-of-contact with vendors/other functions; request locking/archiving of study folders.

Minimum Required Education & Experience:

• Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience.

Preferred Qualifications:

• Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area.
• Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs.
• Knowledge of GCP, ICH, and regulatory requirements (quality oversight/assurance and risk management).
• Strong data analysis, critical thinking, and problem-solving; non-compartmental PK programming experience.
• Ability to oversee TQT, cQT, PK, and PD statistical program development; lead/mentor cross-functional teams.

People Leader Accountabilities:

• Create inclusion, develop talent, and empower teams.

Benefits:

• Company-sponsored medical, dental, vision, and life insurance plans (eligibility per plan terms).