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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.

Role Summary

We are seeking an Associate Director of Statistical Programming. 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.

Key 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

Ideal Candidate

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
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel per business needs (at least 4 – 8 times per year)

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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Associate Director, programming permanent role (Hybrid) at California

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