Sr. Principal Analyst, Statistical Programming

Reporting to the Statistical Programming Manager, West Coast Hub, this role leads and oversees statistical programming activities for internal teams and external vendors at the study or project level, ensuring all deliverables adhere to company SOPs and ICH/GCP guidelines.

Responsibilities

• Leads, coordinates, and manages the timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables for study projects via internal and/or external staff oversight.
• Serves as the Statistical Programming Lead to achieve milestones for a drug program, which may include individual or integrated studies; evaluates task objectives and collaborates with the Project Lead (PL) and/or manager on issues or resource needs.
• Manages end-to-end programming of deliverables from CRF collections through electronic submission, including preparation of electronic submissions (eSUB) components (input to reviewer’s guides, annotated CRF, define, and XPTs); works with SMEs in DS&G to ensure compliance with eSUB standards.
• Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
• Authors CDISC ADaM (analysis data model) analysis data set specifications, including identifying potential data issues or areas of critical data examination.
• Works with statistics teams to define and document programming endpoint algorithms across a study, drug program, and/or contributing to therapeutic area (TA) level algorithms.
• Identifies process inefficiencies and leads efforts to remedy them, training the department on new processes in conjunction with QPT.
• Verifies program consistency and usage of data, analysis, and submission standards across the department in consultation with data standards, statistical submissions management, and the data strategy plan.

Requirements

• Bachelor’s degree required; Master’s or PhD in Statistics or Mathematics preferred.
• 10+ years of relevant work experience within an organization focused on data management and analysis.
• 10+ years of SAS Base programming with 7+ years using SAS STAT, GRAPH, and MACRO.
• 10+ years of relevant industry experience and 5+ years of clinical trial experience.
• 5+ years of clinical database experience.
• CDISC and submissions experience.
• Extensive knowledge of the drug development process and clinical trials.
• Extensive knowledge of drug submission requirements, relevant ICH, FDA/EMEA/ROW guidelines.
• Familiarity with UNIX.
• Strong management skills and ability to effectively lead and collaborate across functions.
• High attention to detail, including proven ability to manage multiple, competing priorities.

Preferred Skills

• Experience with ISS/ISE and NDA/BLA submission.
• Experience with Clinical Trial Efficacy, PKPD, and/or biomarkers.

Pay

The base compensation range for this role is $134,000.00–$179,000.00. Base salary offered is determined through an analytical approach utilizing a combination of factors, including, but not limited to, relevant skills and experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonuses and equity opportunities, designed to reward recent achievements and recognize future potential based on individual, business unit, and company performance.

Benefits

• Medical, dental, vision, and life insurance.
• Fitness and wellness programs, including a fitness reimbursement.
• Short- and long-term disability insurance.
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown (December 26–31).
• Up to 12 company-paid holidays + 3 paid days off for personal significance.
• 80 hours of sick time per calendar year.
• Paid maternity and parental leave.
• 401(k) program participation with company-matched contributions.
• Employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Employee Resource Groups participation.