ClinChoice Inc.
Associate Director, programming permanent role (Hybrid) at California
ClinChoice Inc., Elizabethtown, New York, United States
Associate Director, Biostatistics – Hybrid
Location: United States 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 To apply, please submit your CV via the usual channel. If you meet the requirements, you may be invited for a phone interview as the first step. Due to the volume of applications, we may not respond to all applicants individually. 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. 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 base 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. Equal Employment Opportunity ClinChoice is committed to equal employment opportunity for all applicants and employees. EEO statements and related content have been abbreviated for clarity in this refined description.
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Location: United States 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 To apply, please submit your CV via the usual channel. If you meet the requirements, you may be invited for a phone interview as the first step. Due to the volume of applications, we may not respond to all applicants individually. 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. 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 base 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. Equal Employment Opportunity ClinChoice is committed to equal employment opportunity for all applicants and employees. EEO statements and related content have been abbreviated for clarity in this refined description.
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