Principal Analyst, Statistical Programming
About The Position
The Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Development Unit Lead (DU Lead) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/she leads a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management. This includes communication and quality oversight of the vendor. He/she is comfortable representing the Statistical Programming perspective to the study team and is often the sole functional representative. The Principal Analyst, Statistical Programming helps to implement the Data and Programming Strategy, provides input to the Data Standards personnel and DM on the strategic direction of the program, partners with the PL to ensure appropriate statistical programming standards implementation and serves as reference for the study to Data Standards personnel. He/she develops and implements standard programming practices while also ensuring that they are employed across a study. He/she collaborates on tools and process improvement for Statistical Programming.
Requirements
- Bachelor’s degree required, Masters or PhD in Statistics or Mathematics preferred
- 7+ years relevant work experience within an organization with a focus on data management and analysis
- 7+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO
- 7+ years relevant industry experience
- 7+ years clinical trial experience
- 5+ years clinical database experience
- CDISC and/or submissions experience
- Knowledge of drug development process and clinical trials
- Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines
- Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages)
- Familiarity with AI and ML concepts
Responsibilities
- Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight.
- Authors CDISC ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination.
- Works with statistics on defining and documenting programming endpoint algorithms.
- Manage the 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 to ensure compliance to eSUB standards
- Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with DVAD and PON.
- Serves as the Statistical Programming Lead to achieve milestones for a study; evaluates task objectives, collaborates with PL and/or manager on issues or resource needs.
- 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.
- Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & 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 time off (Dec 26-Dec 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 benefit
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Number of Employees
5,001-10,000 employees
