Business Professional Job In Waltham, Massachusetts
Senior Director, BiostatisticsNext Steps... Apply Now
Job ID 2019-1908
# of Openings 1
Category Biometrics - Dept
The Senior Director Biostatistics oversee all the biostatistics, data management and programming tasks for Radius studies (nonclinical, CMC, clinical, safety, epidemiological or cross-sectional). The role will manage and lead the team to ensure appropriate statistical approaches for the design and analysis of clinical and nonclinical studies are employed and ensure the proper interpretation and presentation of results.
- Oversees and develops the Biometrics team; supervises hiring of team members and conduct development.
- Oversees input on design of study, reviews protocols, and database requirements.
- Provides strategic and critical thinking to support decisions and drive direction of development strategy through collaboration with various business functions
- Conceives and writes SAPs & statistical methods sections for clinical trial and research protocols.
- Performs sample size calculations in conjunction with clinical staff to determine adequate number of research subjects for valid interpretation of results.
- Oversees statistical analysis for all ongoing studies and decided final interpretation in conjunction with other senior researchers and management.
- Plans data subsets to be analyzed.
- Creation and modification of statistical programs to analyze, review or summarize data.
- Conducts statistical analysis and interprets results.
- Prepares statistical reports, tabulations, and graphs for presentation at meetings or conferences, and for publication in technical journals.
- Develops proper statistical methods and formulas for complex study designs.
- Oversees statistical programming and database management personnel involved in clinical data processing, including case report form design, data tracking, data entry codes and document processing.
- Organizes the distribution of tasks and resources in the Biometrics group to maximize quality and to accelerate output by outsourcing non-strategic initiatives.
- Selects in collaboration with Clinical Development, Clinical Operations, QA and Medical Affairs, the CRO(s) that would be contracted and fulfill the corporate requirements.
- Sets up and maintains a preferential relationship with the CRO(s) to ensure success in the deliverables both in time and quality.
- Contributes to the discussion and drafting of Program documents e.g. CDP, SIP (Stats Integration Plans) and the integration of results from entire programs (ISE, ISS, ISI)
- Participates in the due diligence of potential new acquisitions to assess the bio statistical strength of their data.
- Oversees the Data Management Plan for programs and studies.
- Estimates statistical and programming time requirements for team timelines.
- Ensures necessary SOPs are developed or updated to support the quality and timeliness of team deliverables.
- Validates standard programs and macros written by other programmers.
- Guides the drafting and review of the study level documents e.g. SAP, TLF templates.
- Remains current about new developments in Statistics and Data Management and sharing these with R&D groups and teams.
- PhD or equivalent in Statistics, Biostatistics or related discipline required.
- 10+ years of experience in the biotech/pharmaceutical industry.
- Oncology experience highly preferred
- 3+ years of SAS programming experience.
- 10+ years of leadership experience of a bio statistical department.
- Deep understanding of drug development and biopharmaceutical industry
- Strategic and critical thinking to support leadership decisions and drive direction of development strategy
- Strong leadership and management skills, and ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities
- Specialized knowledge and licenses:
- Strong SAS skills in SAS BASE, SAS MACRO, SAS STAT languages.
- Critically review protocol and statistical analysis plan for statistical/programming needs.
- Knowledge of CDISC data standards.
- Program analyses of data from SAS datasets.
- Program outputs e.g. tables, graphs and listings.
- Strong knowledge and solid understanding of clinical trials.
- Strong programming, analytical, verbal, written communication.
- Ability to manage vendors regarding timelines and deliverables.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.