Sr. Director, Biostatistics

Atavistik Bio•Cambridge, MA

1d•$270,000 - $290,000•Hybrid

About The Position

We are seeking a Sr. Director of Biostatistics. Reporting to the Chief Medical Officer. In this position you will be acting as the statistical lead for one program or multiple programs, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will have oversight of the statistics and programming team through an outsourced model. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Requirements

PhD in statistics strongly preferred; Candidates with MS in statistics, biostatistics or mathematics and a depth of relevant experience in drug development statistical research will be considered
A minimum of 8 years experience in progressive and relevant clinical trial experience
Experience leading teams and working in a matrix organization
Experience with blinded study designs and analyzing and interpreting patient reported outcome (PRO) data sets strongly preferred
Ability to communicate and work directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
Experience managing CROs and other data vendors
Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a collaborative work culture
Ability to keep pace in a fast-moving organization and navigate ambiguity
Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including Bayesian method, missing data imputation, multiplicity adjustment
Knowledge and proficiency in SAS or R and other industry computational tools
Knowledge of CDISC standard including SDTM, ADaM
Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
Experience in planning, running and documenting simulations, including clinical trial simulations
Experience working on site and with remote teams
Ability and willingness to travel up to 10% or as needed by the business

Nice To Haves

Experience with blinded study designs and analyzing and interpreting patient reported outcome (PRO) data sets strongly preferred

Responsibilities

Key contributor on regulatory submissions and communication with global regulatory authorities
Provide expert statistical advice, methodological research and analysis of trial and epidemiological data to inform the design, planning and execution of clinical studies
Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents or scientific publications, generates or reviews study randomization, and sample size/power estimations
Oversee and lead the vendor/CRO biostatistics and programming teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses , and providing analyses for publications
Evaluate alternative or innovative approaches to statistical methods and study design
Build relationships with CROs and other external partners to achieve results for specific project needs
Ensure the delivery of high quality and timely reports to project teams and clinical trial team
Develop and maintain statistical/programming policies, guidelines, and procedures (SOPs, training manuals, etc.)