Sr. Analyst, Statistical Programming

Scorpion Therapeutics; Cambridge (MA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental, Vision, Life

401(k) match

Stock purchase plan

Paid time off and holidays

Job summary

Scorpion Therapeutics in Cambridge, MA seeks an experienced Statistical Programmer Lead to own programming activities across multiple trials, from data management through submission.

You will lead CDISC ADaM data set specifications, identify data issues, and document endpoint algorithms while ensuring standards compliance with SMEs in a fast-paced environment.

Qualifications

• Bachelor's degree required.
• 5+ years in data management and analysis.
• 5+ years SAS Base programming with SAS STAT/GRAPH/MACRO.
• 5+ years clinical trial experience.
• 3+ years clinical database experience.
• CDISC and/or submissions experience.
• Knowledge of drug development and clinical trials.
• Familiarity with UNIX and R/imaging/genomics software.

Responsibilities

• Lead and coordinate timely creation, oversight, and delivery of programming activities.
• Author CDISC ADaM analysis data set specifications and document endpoint algorithms.
• Oversee end-to-end programming from CRF to electronic submission with SMEs.
• Serve as Statistical Programming Lead to meet study milestones and resource needs.
• Ensure program consistency and adherence to data, analysis, and submission standards.
• Keep project team informed of requirements, status, and resources.

Skills

SAS Base programming

SAS STAT/GRAPH/MACRO

CDISC/ADaM

Clinical trials

Data management

Unix familiarity

Genomics software knowledge

R basics

Education

Bachelor's degree

Tools

UNIX

Imaging software

Genomics tools

Job description

Role Responsibilities:

• Lead, coordinate, and manage timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables.
• Author CDISC ADaM analysis data set specifications; identify potential data issues and define/document programming endpoint algorithms.
• Manage end-to-end programming from CRF collections through electronic submission, including preparation of electronic submission components; ensure compliance to submission standards with SMEs.
• Serve as Statistical Programming Lead to achieve study milestones; collaborate with Portfolio Lead/manager on issues and resource needs.
• Verify program consistency and usage of data, analysis, and submission standards.
• Inform project team members of programming requirements, deliverable status, and resource needs.

Qualifications/Required Skills:

• Bachelor’s degree.
• 5+ years relevant work experience in data management and analysis.
• 5+ years SAS Base programming with 5+ years using SAS STAT, GRAPH, and MACRO.
• 5+ years relevant industry experience.
• 5+ years clinical trial experience.
• 3+ years clinical database experience.
• CDISC and/or submissions experience.
• Knowledge of drug development process and clinical trials.
• Knowledge of drug submission requirements and relevant ICH and FDA/EMEA/ROW guidelines.
• Some familiarity with UNIX and software development packages (R, imaging, and genomics software).

Benefits/Compensation (as stated):

• Base compensation range: $95,000.00–$130,000.00.
• Medical, Dental, Vision, Life; fitness reimbursement; short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown; paid holidays and personal days; sick time; maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.