Associate Director of Statistical Programming

BioTalent; United States; Remoto; USD 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

BioTalent is seeking an experienced Associate Director of Statistical Programming to join our biometrics team on a contract-to-hire basis. This senior, hands-on role offers ownership of clinical study programming activities in a lean biotech environment, with remote work within the United States.

You will lead programming for database locks, topline readouts, SAP interpretation, and TFL validation, while contributing to R-based reporting and dashboards.

Competenze

• 10+ years of clinical statistical programming experience in biotech/pharma/CRO environments.
• Advanced SAS programming with SDTM/ADaM and TFL development.
• Experience leading statistical programming activities for clinical studies.
• Strong communication and cross-functional collaboration.

Mansioni

• Lead statistical programming activities for assigned studies from planning to database lock.
• Develop, review, validate SAS programs and TFLs.
• Perform QC and troubleshoot programming issues.
• Support database locks, interim analyses and study reporting.
• Collaborate with Biostatistics, Clinical Operations and Data Management.
• Contribute to R-based programming, data visualization, and dashboards.
• Coordinate with cross-functional teams to meet timelines.
• Proactively identify issues and own deliverables.

Conoscenze

Statistical programming

Independent leadership

SAS programming

R programming

Cross-functional collaboration

Communication

Strumenti

SAS

R

Descrizione del lavoro

We are seeking an experienced Associate Director of Statistical Programming to join a growing biometrics team on contract-to-hire basis. This is an ideal opportunity for a highly experienced, hands‑on statistical programmer who enjoys working within a lean biotech environment and wants to take independent ownership of clinical study programming activities.

The immediate focus will be supporting upcoming clinical milestones, including database locks, topline readouts, TFL validation and quality control of existing programming deliverables. While this is a senior‑level position, it is primarily an individual contributor role, rather than a people‑management position.

Responsibilities

• Independently lead statistical programming activities for assigned clinical studies, from planning through database lock and final deliverables.
• Develop, execute, review and validate SAS programs, including SDTM/ADaM datasets and tables, figures and listings (TFLs).
• Perform hands‑on QC, troubleshoot programming issues and ensure the accuracy and quality of statistical outputs.
• Support database locks, interim analyses, topline readouts and clinical study reporting.
• Interpret Statistical Analysis Plans (SAPs) and collaborate closely with Biostatistics, Clinical Operations and Data Management.
• Contribute to R‑based programming activities, including clinical data visualization and dashboard development.
• Coordinate with cross‑functional study teams and external partners to deliver high‑quality outputs against critical timelines.
• Proactively identify issues, recommend solutions and take ownership of programming deliverables.

Qualifications

• 10+ years of clinical statistical programming experience within biotechnology, pharmaceutical or CRO environments.
• Advanced, hands‑on SAS programming expertise, including SDTM, ADaM, TFL development and independent validation.
• Demonstrated experience independently leading statistical programming activities for clinical studies.
• Strong understanding of statistical concepts and the ability to interpret and discuss SAPs with cross‑functional study teams.
• Experience working within small biotech environments, with the ability to manage multiple responsibilities independently.
• Working knowledge of R programming; experience with R‑based clinical reporting or dashboards is highly desirable.
• Strong communication, problem‑solving and stakeholder management skills.
• Flexibility to support occasional evening or weekend work around critical clinical deliverables.

• 40 hours per week; fully remote within the US.
• 12‑month contract with the intention to hire FTE
• W2 or 1099; benefits available for W2.