Senior Statistical Programmer

Redbock - an NES Fircroft company; Remote; USD 100,000 - 125,000; Part time

Job summary

A biotechnology leader is seeking a Study Lead Programmer/FSP Manager to lead clinical studies and manage a team of FSP programmers. This role involves significant hands-on programming for clinical trials, along with overseeing timelines, workload, and productivity. Qualified candidates should have over 12 years of experience in statistical programming within life sciences, demonstrated leadership, and proficiency in regulatory submissions. The position is remote, requiring synchronization with East Coast working hours.

Qualifications

• 12+ years of Statistical Programming experience in life sciences.
• Demonstrated leadership experience in clinical studies.
• Proficiency in CRF annotation and metadata documentation.

Responsibilities

• Lead in-house study and manage assigned FSP programmers.
• Provide programming support for regulatory submissions.
• Hands-on SAS programming for clinical tables and reports.

Skills

Statistical Programming

Leadership

SAS Programming

Clinical Trials

Regulatory Submissions

Job description

Role

STUDY LEAD PROGRAMMER/FSP MANAGER – (1 OPENING) Contract: 12+ MONTHS RENEWABLE Pay Rate: $85-100/hour

Summary

Biotechnology leader on the east coast needs an FSP Manager to support their team. The FSP Manager will be responsible for leading their assigned studies, while also managing the FSP programmers on their study teams. This role will be expected to be very hands‑on with some management responsibilities (70-80% day‑to‑day programming work).

They will need to be experienced lead‑level programmers for clinical trials, with experience leading studies fully in‑house, in addition to having managerial experience. As FSP managers they will be responsible not only for their portion of day‑to‑day programming work, while overseeing other programmers' work, timelines, and productivity.

Duties & Responsibilities

• Study Lead Responsibilities: Responsible for leading in‑house study
• Provide programming support for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
• Hands‑on SAS programming for creation and QC of clinical Tables, Listings and Graphs
• Perform validation and QC of the programs, datasets and statistical reports per study requirements.
• Program and validate ADaM datasets for both safety and efficacy analyses is required
• Deliver end‑to‑end programming of deliverables from CRF design through Electronic Submissions (ESUB) components
• FSP Line management responsibilities: reporting to a client FTE manager, will work in client system and processes as the functional programming workstream FSP lead responsible for trial deliverables
• Will manage FSP programmers on assigned project, assigning workload, managing productivity and providing performance feedback as needed
• Participate in hiring and onboarding of operational FSP programmers

*Responsibilities are not limited to the criteria listed above, and the scope of work may extend beyond the core responsibilities outlined above; therefore, the role may encompass broader duties. A willingness to embrace new challenges is considered an asset, and a flexible, proactive approach is encouraged.

Experience Required

• 12+ years of Statistical Programming experience in life sciences
• Demonstrated leadership experience, including serving as the Point of Contact for multiple studies and leading CRM meetings.
• Technical hands‑on involvement in Phase I, Phase II and Phase III clinical trials, particularly within rare disease indications.
• Proficiency in CRF annotation and metadata documentation is essential, along with strong expertise in drafting and reviewing SDTM and ADaM specifications.
• Must be capable of developing and implementing edit‑check macros and programs to ensure data accuracy and integrity.
• Recent submission experience is a must and comprehensive understanding of regulatory deliverables is expected, including P21 validation, define.xml creation, SDRG, ADRG, and BIMO listings.
• Experience in programming and validating ADaM datasets for both safety and efficacy analyses is required, with a willingness to provide hands‑on support for efficacy programming tasks as needed.

Location

Work will be performed remotely. East Coast working hours must be fully accommodated (9a‑5pm EST).