The Sr. Director of Biostatistics will lead statistical support for clinical studies, oversee biostatistics teams, and ensure statistical integrity in analyses and reports.
Company Summary:
Atavistik Bio is a privately-held clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Our proprietary AMPS™ platform allows us to rapidly unlock functional cryptic pockets across a broad range of target classes to accelerate the development of groundbreaking medicines. We have rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery.
Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, Regeneron Ventures, and RA Capital Management.
Position Summary
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.
Key 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.)
Required Qualifications
- 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
Benefits:
Atavistik Bio offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.
Candidate Privacy Notice:
By submitting your resume/CV and any accompanying materials, you acknowledge and consent to the collection, processing, and storage of your personal information for the purpose of evaluating your candidacy, managing the recruitment process, and communicating with you regarding current or future opportunities. Your information may be accessed by authorized personnel and trusted service providers supporting our hiring activities, and will be retained only as long as necessary to fulfill these purposes or as required by applicable law. We will not sell your data, and we will take reasonable measures to protect it from unauthorized access or disclosure. For more information about how we handle applicant personal information, including the categories of personal information we collect, the purposes for which we use it, whether and how we ‘sell’ or ‘share’ personal information as defined under applicable U.S. state privacy laws, our legal bases for processing (where applicable), and your privacy rights, please review our Privacy Policy. By proceeding, you confirm that the information you submit is accurate and that you understand how it will be used.
Atavistik Bio is an equal opportunity employer. All applicants will be considered for employment without regard to a person's race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any characteristic protected under applicable law.
Atavistik Bio Cambridge, Massachusetts, USA Office
Cambridge, MA, United States, 12139
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