Head of Biostats
Proclinical is currently recruiting for a Head of Biostatistics of Statistical Programming and Data Management with a CRO located in New York, NY. Successful candidate will provide leadership to the Biostatistics, SAS Programming and Data Management groups.
- Manage/build the Biostatistical Services group: Biostatisticians, Director of Statistical Programming and Director of Data Management.
- Ensure collaboration, continuity and efficiencies between the groups and their deliverables.
- Keep Global Head, Operations abreast of any key items/issues that arise; proposes solutions in real time.
- Prioritize and track deliverables and manages timelines.
- Provide statistical expertise in the design of study protocols, sample sizes, analysis and Clinical Study Reports (CSRs).
- Responsible for the timely and successful completion of all statistical deliverables (e.g. Statistical Analysis Plans (SAPs), Tables, Listings and Figures Plans (TLF Plan), randomization plans, Data Safety Monitoring Board plans) and programmed outputs.
- Facilitate and contribute to the development of standard statistical documents including TLF plans, SAPs, Programming (ADaM) specs, SAS macros and SOPs.
- Maintain strong, effective relationships with both internal and external stakeholders.
- Represent (or appoints a representative) during project team meetings and contributes to cross-functional decision making on study design, endpoints, data collection, and analysis strategies.
- Review and provide input into new project proposals/contract development.
Skills and Requirements:
- Master's or PhD degree in Statistics or Biostatistics, required.
- 10+ years of prior statistics experience in a CRO/pharmaceutical environment, required.
- 6+ years of management experience leading biostatistics and programming groups, required.
- Experience with leading/directing data management professionals.
- Familiar with requirements for regulatory submissions (e.g. SDTM, ADaM, eSUB and CDISC requirements).
- Experience with SAS and various sample size software packages.
- Experience with Data Safety Monitoring Boards (DSMBs).
- Prior experience with oncology, required.
- Expertise in statistical concepts and design, as well as SAS programming.
- Demonstrates ability to build and maintain effective relationships with others and establishes collaborative partnerships.
- Strong communication, organization, prioritization, time-management and decision-making skills.
- High level of agility, diplomacy and integrity.
- Energetic and motivated.
- Strong analytical skills.
- Thorough knowledge of SOPs, FDA and ICH guidelines.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Susan Chapman at (+1) 646-542-0158 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.