Director/Senior Director, Biostatistics

Location
USA, USA
Posted
Nov 11, 2020
Ref
193254
Required Education
Doctorate/PHD/MD
Position Type
Full time
Company Description:

Molecular Templates is a clinical-stage company focused on the discovery and development of targeted biologic therapeutics. Our proprietary drug platform technology, known as engineered toxin bodies, or ETBs, leverages the resident biology of a genetically engineered form of Shiga-like Toxin A subunit to create novel therapies with potent and differentiated mechanisms of action for cancer and other serious diseases. For more information, please visit MTEM's website at www.mtem.com

Position Overview:

Molecular Templates is seeking an accomplished, highly-skilled and dynamic Biostatistician professional to lead statistical analysis as part of the clinical development team. This position will be primarily focused on clinical data of ETBs using computational biology. This role will co-author and review protocols and reports and must assure compliance to in-house and/or external specifications and standards (i.e., GCP). This position will require excellent technical, analytical and problem-solving skills, along with ability to operate independently and to collaborate with cross-functional teams, vendors and contractors.

JOB RESPONSIBILITIES:
  • Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenarios.
  • Partner with Health Authorities (e.g. FDA, EMA) on study design and statistical methods in meetings and other negotiations.
  • Perform sample size calculations and write statistical methodology sections for inclusion in study protocols.
  • Oversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents.
  • Liaison with Data Management on statistical questions related to data issues, including coordination of data transfers from Data Management to Statistics
  • Design statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for Biologic License Application (BLA) submissions, and Global Marketing Authorization applications (MAA).
  • Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards, if applicable.
  • Develop SAS programs to produce and/or QC statistical tables/figures/data listings.
  • Perform mapping from raw datasets to CDISC SDTM datasets.
  • Produce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submission.
  • Develop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw data.
  • Review and/or write the statistical and results sections of clinical study reports.
  • Review and/or assist in writing publications.
  • Review case report forms and data validation guidelines to ensure quality and integrity of study data collection.
  • Manage multiple projects.
  • Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as a sponsor's statistician providing data and analysis support for DMC review.
  • Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysis.
  • Support proposal development and attend bid defense meetings.
  • Review Request for Proposal (RFP) and Scope of Work (SOW) documents.
  • Understand the SOW, budget and task assumptions, and track work completed versus budgeted tasks.
  • Manage project budget and forecast resources needed for studies.

EDUCATION/EXPERIENCE:
  • PhD degree in biostatistics, mathematics, statistics, public health or related discipline with 7+ years experience in statistical analysis of clinical trials data or
  • MS degree in biostatistics, mathematics, statistics, public health or related discipline with 10+ years of experience in statistical analysis of clinical trials data.
  • NDA or BLA submission experience
  • Managerial experience

SKILLS:
  • Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methods.
  • Proficiency in SAS statistical programming.
  • Experience to represent biostatistics in bid assessment of external vendors
  • Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH).
  • Familiarity with novel phase 1-3 designs (Bayesian, adaptive, seamless, platform/master protocols etc.) is a plus.
  • Knowledge of other statistical and data management software packages is a plus.
  • Strong written and oral communication skills.


Reporting Structure:

This position will have supervisory responsibilities for Biostatistics and Data Management. This position reports to the Chief Medical Officer.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries, and benefits.



Molecular Templates Inc https://mtem.isolvedhire.com