Associate Director/Director - Biostatistics consultant (Inflammatory and Immune diseases)

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Associate Director/Director, Biostatistics to join one of our clients. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

SUMMARY

We are seeking an Associate Director/Director of Biostatistics. Reporting to the VP of Biometrics. In this position you will be acting as the statistical lead for one or multiple studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistic input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity. Rich experience leading Integrated Summary of Safety, DSUR, IB would be preferred.

RESPONSIBILITIES

• Key contributor on regulatory submissions and communication with global regulatory authorities

• Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of Client clinical studies

• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations

• Oversee and lead the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks

• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Client studies

• Evaluate alternative or innovative approaches to statistical methods and study design

• Build relationships with CROs and other external partners to achieve results for specific project needs

• Ensure the delivery of high quality and timely reports to project teams and clinical trial team

QUALIFICATION

• PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered

• A minimum of 10 years’ experience in progressive and relevant clinical trial experience

• Experience working in a matrix organization

• Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers

• Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly

• 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 and navigate ambiguity

• Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment.

• Knowledge and proficiency in SAS or R and other industry computational tools

• Knowledge of CDISC standard including SDTM, ADaM

• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance

• Experience in planning, running and documenting simulations, including clinical trial simulations

• Experience working with in a remote virtual environment

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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