Associate Director, programming permanent role (Hybrid)

ClinChoice

111d

About The Position

ClinChoice is currently recruiting for a Associate Director of Biostatistics, Hybrid to join our client’s team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment. In this position you will be responsible for leading statistical programming activities to support various clinical trial projects. You will also support building programming processes for clinical studies and submissions as they relate to clinical goals to ensure successful execution of Apogee’s clinical programs. You will manage programmers and CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Requirements

• Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
• A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
• Advanced SAS programming skills and experience in other statistical software, such as R, etc.
• Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
• Phase 3 and BLA submissions experience preferred
• Excellent organizational skills and ability to prioritize tasks
• Excellent communication and interpersonal skills
• Experience managing CROs and other data vendors
• Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Ability to keep pace in a fast-moving organization
• Advanced knowledge of state-of-art statistical programming methods in clinical study setting
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience working in a remote virtual environment
• Ability and willingness to travel per business needs (at least 4 – 8 times per year)

Responsibilities

• Serve as a lead statistical programmer on one or more clinical studies
• Provide statistical programming oversight to programming vendors
• Review and validate datasets and TFLs programmed by vendors
• Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
• Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
• Participate in developing and implementing statistical programming processes and standards
• Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
• Build and mentor a team of programmers to support clinical trials and pipelines
• Generate ad hoc analyses on ongoing basis

Benefits

• Equal opportunity employer
• Diversity and inclusivity in the workplace
• Continuous training and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 51-100 employees