Biostatistics Director

Job Summary:

The Biostatistics Director is responsible for providing statistical expertise for company products within one or more therapeutic areas and establishing strategic plans and objectives for biostatistics for these therapeutic areas. As a lead statistician, the Biostatistics Director will lead study designs, protocol development, analysis plans, file/report specifications, and review study setup activities, including but not limited to randomization, CRFs, and data edits. They will identify appropriate statistical methods, conduct analyses, interpret statistical results, and prepare clinical study reports, including integrated summaries for submissions as appropriate. As an active member of the Biometrics group, they will also aid in process improvement initiatives, stay abreast of current statistical methodology, and manage new/junior biostatisticians.

Essential Duties and Responsibilities:

• Establish strategic plans and objectives for biostatistics in one or more therapeutic area to support clinical development, representing Biostatistics in cross-functional teams.  
• Define statistical methodology, analyze data and reports results, and contribute to the strategic planning and execution of the clinical development plan for the assigned project; train and supervise contract statisticians and ensure their deliverables' quality.
• Serve as a content author or peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel..
• Provide written and verbal responses to statistical issues as part of regulatory, legal, corporate processes; may represent Biostatistics in critical meetings as assigned.
• Participate in approved process improvement initiatives; manage new/junior biostatisticians; keep up-to-date on statistical methodology and software/tools. Conduct modeling and simulations as needed.
• Promote innovative statistical methodology approaches by identifying, adapting, and developing optimal statistical research methodologies and techniques. Contribute internally and externally to the company's development and visibility and the Biometrics department through their expertise and customer orientation 

Education and Experience:

Education:

• PhD (preferred) or master’s degree in Statistics, Biostatistics or related discipline.

Experience:

• 9+ years of related experience in statistical or biostatistical analysis supporting drug development, clinical trial operations, and worldwide regulatory submissions within the pharma/biotech industry
• Experience within oncology is preferred
• Demonstrable knowledge of global regulatory requirements
• Extensive experience with written and verbal communications to regulatory agencies is a must
• Extensive statistical modeling experience including, but not limited to complex statistical methods and models, principles of statistical inference, hypothesis testing, deriving estimates, parametric and non-parametric models, sample size calculations for comparing multiple arms, and phase I-IV clinical trial data analysis. Bayesian and adaptive design experience is preferred
• Ability to translate and implement a broad understanding of statistical principles for all phases of drug development
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• People management experience is preferred

Skills:

Technical:

• Proficient with SAS, Sample size calculation software (e.g., East, PASS, NQuery). R and other analytical software is a plus.
• Demonstrable experience using CDISC data standards, specifically ADaM. SDTM, CDASH, and other CDISC standards are a plus.
• Ability to write statistical code and documentation

Leadership:

• A strong team player and leader, with the ability to lead biostatistics deliverables in a therapeutic area and collaborate in cross-functional teams..
• Able to work cooperatively and independently in a fast-paced, matrixed environment
• Demonstrates ability to translate & present complex information to others effectively.
• Ability to influence without direct authority
• A detail-oriented, pro-active, enthusiastic, and goal-oriented personality  

Communication:

• Excellent communication and interpersonal skills to effectively interface with others
• Must communicate, well with regulatory agencies (e.g., FDA, PMDA, etc.), internal stakeholders, and external stakeholders (e.g., CROs)
• Practical technical writing skills, especially the ability to clearly and succinctly author regulatory documents

Other:

Ability to travel domestically for meetings, as necessary is required

The expected salary range for this position is $178,000 – $235,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance