Associate Director, Biostatistics Cover Letter

I submit this application to express my sincere interest in the associate director, biostatistics position.

Previously, I was responsible for statistical expertise to assist in the proper design of clinical trials studies and statistical methodology, calculates needed sample size and estimates trial power.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• FDA requirements / submission experience
• Experience in working on clinical project teams
• Accurate with a keen eye for detail
• Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump including SAS/GRAPH, SAS/STAT, and R), including report generation is necessary
• Prior experience in electronic NDA/BLA submissions via eCTD
• Experience with CRO oversight and FDA submission preferred
• In-depth knowledge of clinical trials methodology, regulatory requirements, statistics
• Knowledge of QMS-related systems is preferred

I am excited to be applying for the position of associate director, biostatistics. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for strategic and statistical leadership on study designs, statistical analysis plans, data analyses and statistical reports consistent with regulatory requirements or CLSI (Clinical and Laboratory Standards Institute) standards for diagnostic product development and validation.

My experience is an excellent fit for the list of requirements in this job:

• Will be the primary contact for management, CDT/Asset teams, CROs, KOL's in respect to statistical consultation for products within a TA
• PhD in Statistics, Mathematics, or related fields
• Proficiency and extremely hands-on in statistical computing languages including R, SAS
• Familiarity with Data Monitoring Committees and related regulatory guidances
• Experience working with/at a CRO is preferred
• Knowledge of clinical trial design and understanding of statistical applications for clinical trials
• SAS programming skills and an understanding of CDISC models and standards
• Experience as a lead statistician at compound level (preferred)

I am excited to be applying for the position of associate director, biostatistics. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for scientifically rigorous statistical expertise on study design, statistical analysis plans, interpretation and communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.

My experience is an excellent fit for the list of requirements in this job:

• It is important to have strong analytical and technical skills (e.g., Excel, Project, Access, and Shareroom) skills to independently manage multiple tasks simultaneously
• A solid knowledge of ICH GCP and/or a knowledge of the areas spanned by biostatistics, data management, statistical programming, and computer application support services used in clinical development and their interfaces among functions within BDS and outside BDS is important
• PhD/ScD/DPh or equivalent in epidemiology or biostatistics
• Experience in rare disease clinical trials preferred
• Serve as a primary contact with outside investigators (and vendors) in the preparation of scientific presentations and manuscripts
• Interact with external Key Opinion Leaders (KOLs)
• Explore and implements innovative statistical methods
• Experience in other therapeutic areas such as

I submit this application to express my sincere interest in the associate director, biostatistics position.

In the previous role, I was responsible for scientifically rigorous statistical input into regulatory strategy, medical development plans, epidemiology plans, protocol development, regulatory submissions and questions, interpretation of statistical results, study design, statistical analysis plans, business development opportunities and other product support projects.

Please consider my qualifications and experience:

• Extensive experience in contributing to NDAs/BLAs submission and defense preferred
• Experience applying statistical methods to the prospective design and analysis of scientific and/or clinical problems
• Experience running simulations and mixed models
• Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data
• MSc (PhD preferred) in Statistics, Biostatistics, or related field
• Experience with modeling and simulation in early clinical development
• Collaborate with vaccine assay specialists to support vaccine clinical and diagnostic assay development, qualification, and validation
• Collaborate with vaccine preclinical scientists to support vaccine preclinical and nonclinical development

In response to your job posting for associate director, biostatistics, I am including this letter and my resume for your review.

In my previous role, I was responsible for statistical expert support to regulatory submission and clinical studies in design, conduct, analysis, and interpretation of data analysis results.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Excellent influence and leadership skills, and a demonstrated record of strong collaborations with clinicians, pharmacometricians, clinical scientists, and other non-statisticians
• Preference will be given to applicants with experience in administration and leadership
• Good overview-level knowledge of many of the most complex statistical analysis methods that apply to Phase II-III clinical trials, which can be used to cut time, cut costs, and/or increase chance of success
• Good overview knowledge of many of the new and cutting-edge design approaches (including some types of adaptive designs, Bayesian trial design and analysis) that can beneficially be applied to Phase I-III clinical trials
• Good level knowledge of current FDA or EMEA regulatory requirements with respect to study designs, primary endpoints, and acceptable analyses for two or more therapeutic areas
• Good understanding of the clinical drug development process
• High level knowledge of SAS
• PhD in Statistics, Computer Science, Quantitative Genetics, Biostatistics or similar