53 applicants

Company

EyePoint Pharmaceuticals · 2 days ago

Senior Director, Statistical Programming

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

8+ years exp

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BiotechnologyHealth Care

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Responsibilities

Leads statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and approval of programming deliverables.

Participate and provide strategic guidance in study setup, initiation procedures, and review.

Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharma/biotech industry.

Efficiently manage CROs to meet timelines and quality deliveries. Oversee TLFs production and validation, ensuring that CROs, vendors and internal staff meet the highest quality standards.

Establish optimal relationships with internal customers and colleagues and with new or existing strategic partners and vendors.

Contribute to the strategic decision-making process involving programming issues for early to late phase clinical trials.

Communicate how programming decisions impact other functional areas.

Write, review, or approve the data specifications for SDTM and ADaM.

Create or validate SDTM, ADaM, and TLFs.

Track and maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.

Work collaboratively with multiple stakeholders to manage priorities and resources; understand and perform in accordance with regulatory standards and drug development principles.

Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package; plan, develop, test, and document SAS programs and macros for programming efficiency.

Develop and utilize study metrics to monitor quality, project status, activities, and budget to identify trends and provide updates for improvements on operational performance and quality metrics.

Performs supervisory duties as needed including but not limited to interviewing, hiring, training, intervention, discipline, and discharging of staff.

Coaches and mentors staff including initiating and implementing appropriate staff development programs. Meets with staff on a routine basis to review goals and individual development plans.

Develops and maintains SOPs and policies as required to maintain overall quality and consistency of Statistical Programming.

Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.

Ensures that staff levels are adequate in quality and quantity to meet the forecasted workload.

Ensures that appropriate training programs are in place so that staff is adequately and properly trained for their job requirements.

Other duties as assigned.

Qualification

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SASRegulatory submissionsCDISCSDTMADaMStatistical analysisTeam managementContinuous improvementCollaboration skills

Required

Experience supporting regulatory submissions.

Strong analytical and problem-solving skills; expert collaboration and communication skills.

Proficient in SAS and apply SAS programming knowledge to solve problems related to non-routine situations and experienced in interpreting statistical analysis plans and developing analysis data set specifications.

Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.

Ability and interest to work cross functionally.

Highly independent, curious, creative, can-do attitude, and embraces continuous improvement culture.

Have experience in supervising and managing teams.

Have ability to work independently.

Be a team player and work collaboratively and multifunctionally.

At least seven (7) years management experience.

Bachelor’s: ten (10) years of industry related experience.

Master’s: eight (8) years of industry related experience.

8-10+ years in the function and industry.